Trial Outcomes & Findings for Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1 (NCT NCT03739996)
NCT ID: NCT03739996
Last Updated: 2025-05-23
Results Overview
The proportion of participants reporting a grade 3 (severe), grade 4 (potentially life-threatening), or grade 5 (death) adverse event OR premature discontinuation due to an adverse event (regardless of grade) that the clinical management committee judged to be at least possibly related to the CAB LA plus VRC07-523LS combination. Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Measured from Step 2 entry through the remaining study follow-up (e.g., any time on Step 2 or Step 3 for a maximum follow-up time of 96 weeks).
Results posted on
2025-05-23
Participant Flow
Participants enrolled from Dec 2019 to May 2022 at 18 sites in the United States. In Mar 2020 the study temporarily closed to screening and enrollment. During this pause, all participants were taken off the study. The study reopened to screening and enrollment in mid-September 2020. Analyses only included participants who enrolled after the study reopened. All previously enrolled participants were encouraged to return and rescreen. Note: Not all participants who entered Step 1, entered Step 2.
There was no randomization in this study.
Participant milestones
| Measure |
CAB LA + VRC07-523LS
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Step 1 (Oral CAB + 2 NRTIs)
STARTED
|
75
|
|
Step 1 (Oral CAB + 2 NRTIs)
Completed Step 1 and Enrolled to Step 2
|
71
|
|
Step 1 (Oral CAB + 2 NRTIs)
Completed Step 1 and Discontinued the Study
|
3
|
|
Step 1 (Oral CAB + 2 NRTIs)
COMPLETED
|
74
|
|
Step 1 (Oral CAB + 2 NRTIs)
NOT COMPLETED
|
1
|
|
Step 2 (CAB LA + VRC07-523LS)
STARTED
|
71
|
|
Step 2 (CAB LA + VRC07-523LS)
Completed Step 2 and Enrolled to Step 3
|
60
|
|
Step 2 (CAB LA + VRC07-523LS)
Prematurely Discontinued Step 2 and Enrolled to Step 3
|
8
|
|
Step 2 (CAB LA + VRC07-523LS)
Prematurely Discontinued Step 2 and Discontinued the Study
|
3
|
|
Step 2 (CAB LA + VRC07-523LS)
COMPLETED
|
60
|
|
Step 2 (CAB LA + VRC07-523LS)
NOT COMPLETED
|
11
|
|
Step 3 (SOC ART)
STARTED
|
68
|
|
Step 3 (SOC ART)
COMPLETED
|
66
|
|
Step 3 (SOC ART)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
CAB LA + VRC07-523LS
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Step 1 (Oral CAB + 2 NRTIs)
Determined to be ineligible
|
1
|
|
Step 2 (CAB LA + VRC07-523LS)
Death
|
1
|
|
Step 2 (CAB LA + VRC07-523LS)
Adverse Event
|
1
|
|
Step 2 (CAB LA + VRC07-523LS)
Withdrawal by Subject
|
1
|
|
Step 2 (CAB LA + VRC07-523LS)
Virologic failure, as defined by the protocol
|
5
|
|
Step 2 (CAB LA + VRC07-523LS)
Participant refusal to remain on long-acting treatment
|
3
|
|
Step 3 (SOC ART)
Death
|
1
|
|
Step 3 (SOC ART)
Participant moved
|
1
|
Baseline Characteristics
One participant had a missing CD4 count at study entry.
Baseline characteristics by cohort
| Measure |
CAB LA + VRC07-523LS
n=74 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Age, Continuous
|
54 years
n=74 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
White (Non-Hispanic)
|
38 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Black (Non-Hispanic)
|
25 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino (regardless of race)
|
8 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=74 Participants
|
|
Baseline BMI
|
28 kg/m^2
n=74 Participants
|
|
Baseline HIV-1 RNA
Less than 50 copies/mL
|
71 Participants
n=74 Participants
|
|
Baseline HIV-1 RNA
Greater than or equal to 50 copies/mL
|
3 Participants
n=74 Participants
|
|
Baseline CD4 cell count
|
720 cells/mm^3
n=73 Participants • One participant had a missing CD4 count at study entry.
|
|
VRC07-523LS IC50
|
0.076 ug/mL
n=74 Participants
|
|
VRC07-523LS MPI
|
99.9 Percent
n=74 Participants
|
PRIMARY outcome
Timeframe: Measured from Step 2 entry through the remaining study follow-up (e.g., any time on Step 2 or Step 3 for a maximum follow-up time of 96 weeks).Population: All participants who initiated the CAB LA plus VRC07-523LS combination
The proportion of participants reporting a grade 3 (severe), grade 4 (potentially life-threatening), or grade 5 (death) adverse event OR premature discontinuation due to an adverse event (regardless of grade) that the clinical management committee judged to be at least possibly related to the CAB LA plus VRC07-523LS combination. Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=71 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Proportion of Participants Experiencing a Grade 3 or Higher Adverse Event (AE) or Premature Discontinuation Due to an AE (Regardless of Grade) That is Related To Step 2 Study Treatment (CAB LA Plus VRC07-523LS)
|
0.17 Proportion of participants
Interval 0.1 to 0.27
|
PRIMARY outcome
Timeframe: Measured from Step 2 entry through Step 2 Week 44Population: All participants who initiated the CAB LA plus VRC07-523LS combination
Virologic failure is defined as confirmed (i.e., two consecutive values) HIV-1 RNA ≥ 200 copies/mL at or prior to Step 2 Week 44 of the CAB LA plus VRC07-523LS combination.
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=71 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Cumulative Probability of Confirmed Virologic Failure at or Prior to Step 2 Week 44
|
0.07 Cumulative probability
Interval 0.03 to 0.16
|
SECONDARY outcome
Timeframe: Measured at Step 2 Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48Population: All participants who initiated the CAB LA plus VRC07-523LS combination and had PK samples obtained at the scheduled study visits were included.
Concentrations of VRC07-523LS, measured in serum, at selected time points in Step 2.
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=69 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Median Concentrations of VRC07-523LS
Step 2 Week 4
|
177 ug/mL
Interval 159.0 to 200.0
|
|
Median Concentrations of VRC07-523LS
Step 2 Week 8
|
105 ug/mL
Interval 92.2 to 121.0
|
|
Median Concentrations of VRC07-523LS
Step 2 Week 12
|
232 ug/mL
Interval 198.0 to 279.0
|
|
Median Concentrations of VRC07-523LS
Step 2 Week 16
|
146 ug/mL
Interval 114.0 to 160.0
|
|
Median Concentrations of VRC07-523LS
Step 2 Week 20
|
261 ug/mL
Interval 218.0 to 297.0
|
|
Median Concentrations of VRC07-523LS
Step 2 Week 24
|
151 ug/mL
Interval 121.0 to 174.0
|
|
Median Concentrations of VRC07-523LS
Step 2 Week 28
|
264 ug/mL
Interval 233.0 to 306.0
|
|
Median Concentrations of VRC07-523LS
Step 2 Week 32
|
161 ug/mL
Interval 138.0 to 185.0
|
|
Median Concentrations of VRC07-523LS
Step 2 Week 36
|
269 ug/mL
Interval 240.0 to 297.0
|
|
Median Concentrations of VRC07-523LS
Step 2 Week 40
|
156 ug/mL
Interval 139.0 to 185.0
|
|
Median Concentrations of VRC07-523LS
Step 2 Week 44
|
266 ug/mL
Interval 226.0 to 306.0
|
|
Median Concentrations of VRC07-523LS
Step 2 Week 48
|
166 ug/mL
Interval 145.0 to 190.0
|
SECONDARY outcome
Timeframe: Measured at Step 2 Week 4, 8, 24, and 48Population: All participants who initiated the CAB LA plus VRC07-523LS combination and had PK samples obtained at the scheduled study visits were included.
Concentrations of long-acting cabotegravir, measured in plasma, at select time points in Step 2
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=70 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Median Concentration of CAB LA
Step 2 Week 4
|
1398 ng/mL
Interval 891.0 to 2201.0
|
|
Median Concentration of CAB LA
Step 2 Week 8
|
1714 ng/mL
Interval 1376.0 to 2503.0
|
|
Median Concentration of CAB LA
Step 2 Week 24
|
2386 ng/mL
Interval 1857.0 to 2886.0
|
|
Median Concentration of CAB LA
Step 2 Week 48
|
2760 ng/mL
Interval 2125.0 to 3234.0
|
SECONDARY outcome
Timeframe: Measured from Step 2 entry through Step 2 Week 48Population: Participants with confirmed virologic failure (two consecutive HIV-1 RNA values ≥ 200 copies/mL) who initiated the VRC07-523LS + CAB LA combination and had reportable assay results.
ARV resistance testing was conducted on samples obtained when confirmed virologic failure (two consecutive HIV-1 RNA values ≥ 200 copies/mL) occurred. Interpretation of resistance results, pertaining to integrase inhibitor resistance mutations, was obtained using the Stanford HIVDB Algorithm Version 9.3 (released 2022-11-20).
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=4 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
ARV Resistance of Breakthrough Isolates
Susceptible
|
3 Participants
|
|
ARV Resistance of Breakthrough Isolates
Intermediate or Low-Level Resistance
|
1 Participants
|
SECONDARY outcome
Timeframe: Measured from Step 2 entry through Step 2 Week 24Population: All participants who initiated the CAB LA plus VRC07-523LS combination
Virologic failure defined as confirmed (i.e., two consecutive values) HIV-1 RNA ≥ 200 copies/mL
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=71 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Cumulative Probability of Confirmed Virologic Failure at or Prior to Step 2 Week 24
|
0.04 Cumulative probability
Interval 0.01 to 0.12
|
SECONDARY outcome
Timeframe: Measured from Step 2 entry through Step 2 Week 44Population: All participants initiating the CAB LA plus VRC07-523LS combination
Virologic failure, defined as confirmed (i.e., two consecutive values) HIV-1 RNA ≥ 200 copies/mL or premature treatment discontinuation, defined as the date at which a participant ended Step 2 treatment (CAB LA and VRC07-523LS), for any reason, without receiving all 12 CAB LA injections and 6 VRC07-523LS infusions, at or prior to Step 2 Week 44.
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=71 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Cumulative Probability of Confirmed Virologic Failure or Premature Treatment Discontinuation at or Prior to Step 2 Week 44
|
0.14 Cumulative probability
Interval 0.08 to 0.24
|
SECONDARY outcome
Timeframe: Measured from Step 2 entry through Step 2 Week 44Population: All participants who intiated the CAB LA plus VRC07-523LS combination
Confirmed (i.e., two consecutive values) HIV-1 RNA ≥ 50 copies/mL measured at or prior to Step 2 Week 44.
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=71 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Cumulative Probability of Confirmed HIV-1 RNA ≥ 50 Copies/mL at or Prior to Step 2 Week 44
|
0.13 Cumulative probability
Interval 0.07 to 0.23
|
SECONDARY outcome
Timeframe: Measured from Step 2 entry through Step 2 Week 24Population: All participants who initiated the CAB LA plus VRC07-523LS combination
Confirmed (i.e., two consecutive values) HIV-1 RNA ≥ 50 copies/mL measured at or prior to Step 2 Week 24.
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=71 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Cumulative Probability of Confirmed HIV-1 RNA ≥ 50 Copies/mL at or Prior to Step 2 Week 24
|
0.12 Cumulative probability
Interval 0.06 to 0.21
|
SECONDARY outcome
Timeframe: Measured from Step 2 entry through Step 2 Week 44Population: All participants who initiated the CAB LA plus VRC07-523LS combination
Confirmed (i.e., two consecutive values) HIV-1 RNA ≥ 50 copies/mL or premature treatment discontinuation, defined as the date at which a participant ended Step 2 treatment (CAB LA and VRC07-523LS), for any reason, without receiving all 12 CAB LA injections and 6 VRC07-523LS infusions, at or prior to Step 2 Week 44.
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=71 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Cumulative Probability of Confirmed HIV-1 RNA ≥ 50 Copies/mL or Premature Treatment Discontinuation at or Prior to Step 2 Week 44
|
0.20 Cumulative probability
Interval 0.12 to 0.3
|
SECONDARY outcome
Timeframe: Step 2 Week 44Population: All participants who initiated the CAB LA plus VRC07 combination.
The proportion of participants with HIV-1 RNA ≥ 50 copies/mL, HIV-1 RNA \< 50 copies/mL, and without data in Step 2 Week 44 window (days 295-322 from Step 2 entry) as defined by the FDA Snapshot algorithm.
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=71 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Step 2 Week 44
HIV-1 RNA ≥ 50 copies/mL on treatment
|
7 Participants
|
|
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Step 2 Week 44
HIV-1 RNA < 50 copies/mL on treatment
|
58 Participants
|
|
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Step 2 Week 44
No Virologic Data in Week 44 Window: Disc study/study drug due to an AE or death
|
3 Participants
|
|
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Step 2 Week 44
No Virologic Data in Week 44 Window: Disc study/study drug for other reasons
|
2 Participants
|
|
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Step 2 Week 44
No Virologic Data in Week 44 Window: On study but missing data in window
|
1 Participants
|
SECONDARY outcome
Timeframe: Measured at Step 2 Week 28 and 48Population: All participants who initiated the CAB LA plus VRC07-523LS combination and had ADA samples obtained at the scheduled study visit were included.
Number of participants who were anti-drug antibody (ADA) negative or ADA positive calculated at each sampled timepoint.
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=61 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Frequency of Anti-Drug Antibodies (ADA) Against VRC07-523LS
Step 2 Week 28 · ADA Negative
|
61 Participants
|
|
Frequency of Anti-Drug Antibodies (ADA) Against VRC07-523LS
Step 2 Week 28 · ADA Positive
|
0 Participants
|
|
Frequency of Anti-Drug Antibodies (ADA) Against VRC07-523LS
Step 2 Week 48 · ADA Negative
|
59 Participants
|
|
Frequency of Anti-Drug Antibodies (ADA) Against VRC07-523LS
Step 2 Week 48 · ADA Positive
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured from Step 1 entry through the end of Step 1 (for a maximum of 5 weeks)Population: All eligible participants who initiated oral CAB.
The proportion of participants reporting a grade 3 (severe), grade 4 (potentially life-threatening), or grade 5 (death) adverse event OR premature discontinuation due to an adverse event (regardless of grade) that the clinical management committee judged to be at least possibly related to oral CAB. Based on the Division of AIDS Table for Grading the Severity of Adult and Pedatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017.
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=74 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Proportion of Participants Experiencing a Grade 3 or Higher Adverse Event (AE) or Premature Discontinued Due to an AE (Regardless of Grade) That is Related to Oral CAB.
|
0 Proportion of participants
Interval 0.0 to 0.05
|
SECONDARY outcome
Timeframe: Measured from Step 1 entry through the end of Step 2 (for a maximum of 53 weeks)Population: All eligible participants who initiated Step 1 (oral CAB) and all participants who initiated Step 2 (CAB LA plus VRC07-523LS) treatment
The proportion of participants who discontinued, for any reason, oral CAB (during Step 1) or the CAB LA plus VRC07-523LS combination.
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=74 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Proportion of Participants Who Prematurely Discontinued Oral CAB or the CAB LA Plus VRC07-523LS Combination
|
10 Participants
|
SECONDARY outcome
Timeframe: Measured from Step 1 entry through entire study follow-up (for a maximum of 101 weeks)Population: All eligible participants who initiated oral CAB and all participants who initiated the CAB LA plus VRC07-523LS combination
The proportion of participants reporting a grade 3 (severe), grade 4 (potentially life-threatening), or grade 5 (death) that the clinical management committee judged to be at least possibly related to oral CAB or the CAB LA plus VRC07-523LS combination. Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017.
Outcome measures
| Measure |
CAB LA + VRC07-523LS
n=74 Participants
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|
|
Proportion of Participants Experiencing a Grade 3 or Higher Adverse Event (AE) That is Related to Oral CAB or the CAB LA Plus VRC07-523LS Combination.
|
0.15 Proportion of participants
Interval 0.09 to 0.25
|
Adverse Events
Step 1: Oral CAB Plus 2 NRTIs
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Step 2: CAB LA + VRC07-523LS
Serious events: 9 serious events
Other events: 37 other events
Deaths: 1 deaths
Step 3: Standard of Care ART
Serious events: 6 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Step 1: Oral CAB Plus 2 NRTIs
n=74 participants at risk
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
|
Step 2: CAB LA + VRC07-523LS
n=71 participants at risk
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
|
Step 3: Standard of Care ART
n=68 participants at risk
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Infections and infestations
Neurosyphilis
|
1.4%
1/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
Other adverse events
| Measure |
Step 1: Oral CAB Plus 2 NRTIs
n=74 participants at risk
Step 1: CAB administered orally as one 30 mg tablet once daily, plus two NRTIs, for up to 5 weeks.
Oral Cabotegravir (CAB): 30 mg tablets administered orally Nucleoside Reverse Transcriptase Inhibitors (NRTIs): NRTIs were not provided by the study. Participants obtained NRTIs outside of the study through routine care.
|
Step 2: CAB LA + VRC07-523LS
n=71 participants at risk
Step 2: CAB LA loading dose (600 mg) administered as one IM injection at Step 2 entry study visit, and maintenance dose (400 mg), starting at 4 weeks after CAB LA loading dose, and then every 4 weeks through Week R2+44 (for a total of 12 injections).
VRC07-523LS (40 mg/kg) administered as an IV infusion starting at Step 2 entry and then every 8 weeks through Week R2+40 (for a total of 6 infusions).
Long-Acting Injectable Cabotegravir (CAB LA): 600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection VRC07-523LS: 40 mg/kg administered as an intravenous (IV) infusion
|
Step 3: Standard of Care ART
n=68 participants at risk
Step 3: Standard of Care (SOC) ART regimen for approximately 48 weeks.
Standard of Care (SOC) ART: SOC ART was not provided by the study. Participants obtained SOC ART outside of the study through routine care.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
General disorders
Chills
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
7.0%
5/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
General disorders
Fatigue
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
2.8%
2/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
General disorders
Malaise
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
General disorders
Pain
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Infections and infestations
COVID-19
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
2.8%
2/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Blood bilirubin
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Blood creatine phosphokinase
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
2.9%
2/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
5.6%
4/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
2.9%
2/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Blood creatinine increased
|
1.4%
1/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
2.8%
2/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
2.9%
2/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
2.8%
2/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
5.9%
4/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Blood glucose increased
|
5.4%
4/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
5.6%
4/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Blood pressure increased
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Creatinine renal clearance decreased
|
6.8%
5/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
19.7%
14/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
19.1%
13/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
2.8%
2/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Lipase increased
|
2.7%
2/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
11.3%
8/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
8.8%
6/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Investigations
Weight decreased
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
2.8%
2/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
2.8%
2/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Nervous system disorders
Headache
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
2.8%
2/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.5%
1/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Vascular disorders
Hypotension
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
|
Vascular disorders
Vasospasm
|
0.00%
0/74 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
1.4%
1/71 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
0.00%
0/68 • Step 1: From study entry through step completion or premature discontinuation of study/Step 1 (maximum time in Step 1 was 5 weeks). Step 2: From Step 2 entry through step completion or premature discontinuation of study/Step 2 (maximum time in Step 2 was 48 weeks). Step 3: From Step 3 entry through study completion of premature discontinuation (maximum time in Step 3 was 48 weeks).
* Grade ≥ 3 AEs * Grade ≥ 2 lab findings * All AEs that led to a change in study treatment, regardless of grade * All AEs meeting SAE definition or EAE reporting requirement The DAIDS AE Grading Table (V2.1), July 2017 was used. All eligible participants who entered Step 1 are included. For eligible participants who entered Step 2, AEs occurring in Step 2 are shown separately. All participants in Step 2 were eligible for Step 3. AEs occurring in Step 3 are shown in a separate column.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company
Phone: ACTG Network Coordinating Cent
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER