Trial Outcomes & Findings for Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection (NCT NCT00440947)
NCT ID: NCT00440947
Last Updated: 2012-03-22
Results Overview
The percentage of PAR with HIV-1 RNA virus \<50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (\<100,000 c/ml and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50 c/ml, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/ml, or had an unconfirmed HIV RNA of at least 50 c/ml at last visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
515 participants
Primary outcome timeframe
Week 84
Results posted on
2012-03-22
Participant Flow
Participants (PAR) were recruited at 66 centers in the United States of America and Canada. HIV-RNA, human immunodeficiency virus-ribonucleic acid; ml, milliliters.
The study had a 36-week Non-randomized Induction Phase, followed by an 84-week Randomized Phase. All PAR completing 84 weeks were eligible to enter an optional 60-week extension phase (EP); some PAR chose not to continue in the EP. PAR whose HIV-RNA wasn't \<50 copies/ml before Week 36 weren't allowed to randomize at Week 36 and were withdrawn.
Participant milestones
| Measure |
ABC/3TC + ATV/r: Induction Phase
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
|
ABC/3TC + ATV: Randomization Phase
Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with 400 mg ATV QD
|
ABC/3TC + ATV/r: Randomization Phase
Continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
ABC/3TC + ATV: Extension Phase
Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Extension Phase
Continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
|
|---|---|---|---|---|---|
|
36-Week Induction Phase
STARTED
|
515
|
0
|
0
|
0
|
0
|
|
36-Week Induction Phase
COMPLETED
|
442
|
0
|
0
|
0
|
0
|
|
36-Week Induction Phase
NOT COMPLETED
|
73
|
0
|
0
|
0
|
0
|
|
48-Week Randomization Phase
STARTED
|
0
|
210
|
209
|
0
|
0
|
|
48-Week Randomization Phase
COMPLETED
|
0
|
194
|
185
|
0
|
0
|
|
48-Week Randomization Phase
NOT COMPLETED
|
0
|
16
|
24
|
0
|
0
|
|
Optional 60-Week Extension Phase
STARTED
|
0
|
0
|
0
|
189
|
180
|
|
Optional 60-Week Extension Phase
COMPLETED
|
0
|
0
|
0
|
160
|
154
|
|
Optional 60-Week Extension Phase
NOT COMPLETED
|
0
|
0
|
0
|
29
|
26
|
Reasons for withdrawal
| Measure |
ABC/3TC + ATV/r: Induction Phase
Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
|
ABC/3TC + ATV: Randomization Phase
Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with 400 mg ATV QD
|
ABC/3TC + ATV/r: Randomization Phase
Continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
ABC/3TC + ATV: Extension Phase
Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Extension Phase
Continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
|
|---|---|---|---|---|---|
|
36-Week Induction Phase
Adverse Event
|
16
|
0
|
0
|
0
|
0
|
|
36-Week Induction Phase
Insufficient Viral Load Response
|
11
|
0
|
0
|
0
|
0
|
|
36-Week Induction Phase
Protocol-defined Virologic Failure
|
5
|
0
|
0
|
0
|
0
|
|
36-Week Induction Phase
Non-compliance
|
10
|
0
|
0
|
0
|
0
|
|
36-Week Induction Phase
Lost to Follow-up
|
16
|
0
|
0
|
0
|
0
|
|
36-Week Induction Phase
Withdrawal by Subject
|
7
|
0
|
0
|
0
|
0
|
|
36-Week Induction Phase
Kaposi Lesions Requiring Chemotherapy
|
1
|
0
|
0
|
0
|
0
|
|
36-Week Induction Phase
Took Exclusionary Medications
|
1
|
0
|
0
|
0
|
0
|
|
36-Week Induction Phase
Genotype Had Exclusionary Mutations
|
1
|
0
|
0
|
0
|
0
|
|
36-Week Induction Phase
Fleeing Police; Outstanding Warrants
|
1
|
0
|
0
|
0
|
0
|
|
36-Week Induction Phase
Incarceration
|
3
|
0
|
0
|
0
|
0
|
|
36-Week Induction Phase
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
|
48-Week Randomization Phase
Adverse Event
|
0
|
2
|
5
|
0
|
0
|
|
48-Week Randomization Phase
Protocol-defined Virologic Failure
|
0
|
1
|
1
|
0
|
0
|
|
48-Week Randomization Phase
Non-compliance
|
0
|
3
|
4
|
0
|
0
|
|
48-Week Randomization Phase
Lost to Follow-up
|
0
|
2
|
8
|
0
|
0
|
|
48-Week Randomization Phase
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
|
48-Week Randomization Phase
Withdrawal by Subject
|
0
|
2
|
4
|
0
|
0
|
|
48-Week Randomization Phase
Pregnancy
|
0
|
0
|
1
|
0
|
0
|
|
48-Week Randomization Phase
Incarceration
|
0
|
3
|
0
|
0
|
0
|
|
48-Week Randomization Phase
Trying to Get Pregnant
|
0
|
1
|
0
|
0
|
0
|
|
48-Week Randomization Phase
Physician Decision
|
0
|
2
|
0
|
0
|
0
|
|
Optional 60-Week Extension Phase
Adverse Event
|
0
|
0
|
0
|
1
|
3
|
|
Optional 60-Week Extension Phase
Insufficient Viral Load Response
|
0
|
0
|
0
|
1
|
1
|
|
Optional 60-Week Extension Phase
Protocol-defined Virologic Failure
|
0
|
0
|
0
|
3
|
2
|
|
Optional 60-Week Extension Phase
Non-compliance
|
0
|
0
|
0
|
1
|
1
|
|
Optional 60-Week Extension Phase
Lost to Follow-up
|
0
|
0
|
0
|
9
|
9
|
|
Optional 60-Week Extension Phase
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
|
Optional 60-Week Extension Phase
Withdrawal by Subject
|
0
|
0
|
0
|
4
|
3
|
|
Optional 60-Week Extension Phase
Pregnancy
|
0
|
0
|
0
|
3
|
0
|
|
Optional 60-Week Extension Phase
Participant Moved
|
0
|
0
|
0
|
1
|
1
|
|
Optional 60-Week Extension Phase
Sponsor Request
|
0
|
0
|
0
|
1
|
1
|
|
Optional 60-Week Extension Phase
Sponsor Terminated Site
|
0
|
0
|
0
|
3
|
3
|
|
Optional 60-Week Extension Phase
Other
|
0
|
0
|
0
|
1
|
0
|
|
Optional 60-Week Extension Phase
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
|
Optional 60-Week Extension Phase
Participant Remained in Cuba
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection
Baseline characteristics by cohort
| Measure |
ABC/3TC + ATV/r
n=515 Participants
All participants starting the Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
|
|---|---|
|
Age Continuous
|
38.3 Years
STANDARD_DEVIATION 10.03 • n=93 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
429 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
167 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
9 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
4 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
3 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
1 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
3 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
5 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
316 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
6 participants
n=93 Participants
|
|
Number of participants with the indicated baseline HIV-RNA level
HIV-1 RNA <100,000
|
227 participants
n=93 Participants
|
|
Number of participants with the indicated baseline HIV-RNA level
HIV-1 RNA 100,000-<250,000
|
143 participants
n=93 Participants
|
|
Number of participants with the indicated baseline HIV-RNA level
HIV-1 RNA 250,000-<500,000
|
73 participants
n=93 Participants
|
|
Number of participants with the indicated baseline HIV-RNA level
HIV-1 RNA >=500,000
|
72 participants
n=93 Participants
|
|
Number of participants with the indicated Baseline CD4+ Cell Count
CD4+ cells <50
|
69 participants
n=93 Participants
|
|
Number of participants with the indicated Baseline CD4+ Cell Count
CD4+ cells 50-<200
|
190 participants
n=93 Participants
|
|
Number of participants with the indicated Baseline CD4+ Cell Count
CD4+ cells >=200
|
256 participants
n=93 Participants
|
|
Number of participants with the indicated Center for Disease Control (CDC) Classification
Asymptomatic HIV Infection
|
353 participants
n=93 Participants
|
|
Number of participants with the indicated Center for Disease Control (CDC) Classification
Symptomatic (non-AIDS) condition
|
97 participants
n=93 Participants
|
|
Number of participants with the indicated Center for Disease Control (CDC) Classification
AIDS
|
65 participants
n=93 Participants
|
|
Median Baseline CD4+ Cell Count
|
199 cells per cubic millimeter
n=93 Participants
|
|
Median Baseline HIV-1 RNA Level
|
5.076 log10 copies/ml
n=93 Participants
|
PRIMARY outcome
Timeframe: Week 84Population: Intent-to-Treat (ITT)-Exposed Population, Randomized Phase: all PAR exposed to at least one dose of study medication during the Randomized Phase of the study. The primary analysis method was time to loss of virologic response (TLOVR) for the proportion of PAR with HIV-1 RNA \<50 c/ml at Week 84 in the Simplification arm and Continuation arms
The percentage of PAR with HIV-1 RNA virus \<50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (\<100,000 c/ml and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50 c/ml, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/ml, or had an unconfirmed HIV RNA of at least 50 c/ml at last visit.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=210 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=209 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit
|
86 percentage of participants
|
81 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of Randomized PhasePopulation: ITT-E Population: all participants exposed to at least one dose of study medication during the Randomized Simplification Phase
The mean age of participants randomized to treatment in the Randomized Phase was calculated at Baseline.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=210 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=209 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Mean Age at Baseline of Participants Randomized to Treatment for the 48-Week Randomized Phase
|
37.5 years
Standard Deviation 10.23
|
39.7 years
Standard Deviation 9.71
|
SECONDARY outcome
Timeframe: Week 36Population: ITT-E Population, Induction Phase: all participants exposed to at least one dose of study medication during the Induction Phase of the study
The percentage of PAR with HIV-1 RNA virus \<50 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50 c/ml, prematurely discontinued (DC) study or study medication (any reason), had confirmed rebound to \>=50 c/ml, or had an unconfirmed HIV RNA \>=50 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study medication DC were failures.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=515 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit
TLOVR
|
80 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit
Obs
|
88 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 36 Visit
M/D=F
|
77 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 84Population: ITT-E Population, Randomized Phase. The secondary analysis methods were Observed (Obs) and missing/discontinuation=failure (M/D=F) analyses.
A blood sample was drawn to determine the amount of HIV-1 RNA virus in c/ml at Week 84. The percentage of participants with HIV-1 RNA \<50 c/ml at Week 84 was tabulated. The secondary analysis methods were: Observed (Obs; uses all visits with data in the analysis period), and missing/discontinuation=failure (M/D=F) analyses. M/D=F: participants with missing data or data collected after study medication DC were considered failures.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=210 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=209 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit
Obs
|
92 percentage of participants
|
92 percentage of participants
|
|
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 84 Visit
M/D=F
|
85 percentage of participants
|
82 percentage of participants
|
SECONDARY outcome
Timeframe: Week 144Population: ITT-Extension Population, Extension Phase: all participants exposed to at least one dose of study medication during the Extension Phase of the study
Percentage of PAR with HIV-1 RNA \<50 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (\<100,000 and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA \<50 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA \<50 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to \>=50 c/ml, or had an unconfirmed HIV RNA \>=50 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=189 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=180 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit
M/D=F
|
80 percentage of participants
|
78 percentage of participants
|
|
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit
TLOVR
|
77 percentage of participants
|
73 percentage of participants
|
|
Percentage of Participants Who Achieved Plasma HIV-1 RNA <50 c/ml at the Week 144 Visit
Obs
|
95 percentage of participants
|
92 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: ITT-E Population, Induction Phase
The percentage of PAR with HIV-1 RNA virus \<400 c/ml from a Week 36 blood sample was tabulated. Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV RNA \<400 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved CF HIV RNA \<400 c/ml, prematurely discontinued (DC) study or study medication (Med; any reason), had CF rebound to \>=400 c/ml, or had an unconfirmed HIV RNA \>=400 c/ml at last visit. ITT-E observed analysis (Obs): all observed data. ITT-E M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=515 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit
TLOVR
|
82 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit
Obs
|
98 percentage of participants
|
—
|
|
Percentage of Participants Who Achieved Plasma HIV-1 RNA <400 c/ml at the Week 36 Visit
M/D=F
|
84 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 84Population: ITT-E Population, Randomized Phase
Percentage of PAR with HIV-1 RNA \<400 c/ml at Week 84 was tabulated; stratified by baseline HIV-1 RNA (\<100,000 and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA \<400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA \<400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to \>=400 c/ml, or had an unconfirmed HIV RNA \>=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=210 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=209 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit
TLOVR
|
92 percentage of participants
|
86 percentage of participants
|
|
Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit
Obs
|
99 percentage of participants
|
98 percentage of participants
|
|
Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 84 Visit
M/D=F
|
92 percentage of participants
|
87 percentage of participants
|
SECONDARY outcome
Timeframe: Week 144Population: ITT-Extension Population, Extension Phase
Percentage of PAR with HIV-1 RNA \<400 c/ml at Week 144 was tabulated; stratified by baseline HIV-1 RNA (\<100,000 and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed (CF) HIV-RNA \<400 c/ml who had not met any non-responder (NR) criterion. NR were PAR who never achieved CF HIV RNA \<400 c/ml, prematurely discontinued (DC) study or study medication (Med), had CF rebound to \>=400 c/ml, or had an unconfirmed HIV RNA \>=400 c/ml at last visit. Observed analysis (Obs): all observed data. M/D=F analysis: PAR with missing data/data collected after study Med DC were failures.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=189 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=180 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit
TLOVR
|
84 percentage of participants
|
80 percentage of participants
|
|
Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit
Obs
|
99 percentage of participants
|
97 percentage of participants
|
|
Percentage of Participants Who Achieved HIV-1 RNA <400 c/ml at the Week 144 Visit
M/D=F
|
84 percentage of participants
|
82 percentage of participants
|
SECONDARY outcome
Timeframe: Week 36Population: ITT-E Population, Induction Phase
The number of participants that failed to respond to therapy through 36 weeks on treatment, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA \<400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound \>=400 c/ml after achieving HIV-1 \<400 c/ml.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=515 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36
Protocol-defined virologic failure
|
15 participants
|
—
|
|
Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36
Failure to achieve <400 c/ml by Week 30
|
5 participants
|
—
|
|
Number of Participants Who Met the Protocol-defined Virologic Failure (PDVF) Criteria at Week 36
Confirmed rebound after achieving <400 c/ml
|
10 participants
|
—
|
SECONDARY outcome
Timeframe: Week 84Population: ITT-Exposed Population, Randomized Phase. TLOVR. One participant met PDVF criteria at Week 36 and was included in the Week 36 PDVF but had been randomized; this participant is therefore also included in this PDVF tabulation.
The number of participants that failed to respond to therapy from the time of treatment randomization through Week 84, based on the protocol definition of virologic failure (PDVF), was tabulated. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA \<400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound \>=400 c/ml after achieving HIV-1 \<400 c/ml.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=210 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=209 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Number of Participants Who Met the PDVF Criteria at Week 84
Confirmed rebound after achieving <400 c/ml
|
1 participants
|
7 participants
|
|
Number of Participants Who Met the PDVF Criteria at Week 84
Protocol-defined virologic failure
|
1 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Week 144Population: ITT-Extension Population, Extension Phase. TLOVR.
The number of participants enrolled in the extension phase that failed to respond to therapy from Week 84 through Week 144, based on the protocol definition of virologic failure (PDVF) was tabulated,. PDVF was defined as (a) failure to achieve plasma HIV-1 RNA \<400 c/ml by Week 30 or (b) confirmed HIV-1 RNA rebound \>=400 c/ml after achieving HIV-1 \<400 c/ml.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=210 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=209 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Number of Participants Who Met the PDVF Criteria at Week 144
Protocol-defined virologic failure
|
5 participants
|
6 participants
|
|
Number of Participants Who Met the PDVF Criteria at Week 144
Confirmed rebound after achieving <400 c/ml
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: ITT-E Population, Induction Phase. Observed Population. Participants could only be included in the analysis if they had completed a Week 36 visit and had a viral load result obtained during that visit period.
Change from baseline was calculated as the Week 36 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=447 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Change From Baseline in HIV-1 RNA at Week 36
|
-3.241 log10 c/ml
Standard Deviation 0.775
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 84Population: ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a viral load result obtained during that visit period.
Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=194 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=187 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Change From Baseline in HIV-1 RNA at Week 84
|
-3.261 log10 c/ml
Standard Deviation 0.681
|
-3.270 log10 c/ml
Standard Deviation 0.698
|
SECONDARY outcome
Timeframe: Baseline and Week 144Population: ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a viral load result obtained during that visit period.
Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for plasma HIV viral load.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=163 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=154 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Change From Baseline in HIV-1 RNA at Week 144
|
-3.291 log10 c/ml
Standard Deviation 0.675
|
-3.239 log10 c/ml
Standard Deviation 0.835
|
SECONDARY outcome
Timeframe: Baseline and Week 36Population: ITT-E Population, Induction Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 36 visit and had a cell count obtained during that visit period.
Blood was drawn to analyze for CD4+ cell count. A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 36 value minus the baseline value.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=438 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 36
|
185.4 cells/millimeters cubed (mm^3)
Standard Deviation 121.84
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 84Population: ITT-E Population, Randomized Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 84 visit and had a cell count obtained during that visit period.
A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 84 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=193 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=187 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 84
|
265.7 cells/millimeters cubed (mm^3)
Standard Deviation 157.65
|
282.9 cells/millimeters cubed (mm^3)
Standard Deviation 150.49
|
SECONDARY outcome
Timeframe: Baseline and Week 144Population: ITT-Extension Population, Extension Phase. Observed Population. Participants withdrew as the study progressed; participants could only be included in the analysis if they had completed a Week 144 visit and had a cell count obtained during that visit period.
A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts. Change from baseline was calculated as the Week 144 value minus the baseline value. Blood was drawn to analyze for CD4+ cell count.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=163 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=156 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Change From Baseline in CD4+ Cell Count at Week 144
|
317.7 cells/millimeters cubed (mm^3)
Standard Deviation 161.98
|
325.1 cells/millimeters cubed (mm^3)
Standard Deviation 178.29
|
SECONDARY outcome
Timeframe: Baseline through Week 36Population: Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.
A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New resistance-associated mutations (defined by the International AIDS Society-USA guidelines) that developed at the time of failure were tabulated by drug class. PAR, participants; VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=15 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36
PAR with treatment-emergent mutations
|
6 participants
|
—
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36
PAR with NRTI mutations
|
4 participants
|
—
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36
PAR with NNRTI mutations
|
1 participants
|
—
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36
PAR with major PI mutations
|
0 participants
|
—
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36
PAR with paired genotypes at baseline and VF
|
15 participants
|
—
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 36
PAR with minor PI mutations
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: Randomization at Week 36 through Week 84Population: Participants in the ITT-E Population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure genotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.
A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=1 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=7 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84
PAR with minor PI mutations
|
0 participants
|
2 participants
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84
PAR with paired genotypes at baseline and VF
|
1 participants
|
7 participants
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84
PAR with treatment-emergent mutations
|
1 participants
|
2 participants
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84
PAR with NRTI mutations
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84
PAR with NNRTI mutations
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Randomization at Week 36 Through Week 84
PAR with major PI mutations
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 84 through Week 144Population: Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure genotypic evaluations.
A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDs Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=5 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=6 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144
PAR with paired genotypes at baseline and VF
|
5 participants
|
5 participants
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144
PAR with treatment-emergent mutations
|
2 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144
PAR with NRTI mutations
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144
PAR with NNRTI mutations
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144
PAR with major PI mutations
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Week 84 Through Week 144
PAR with minor PI mutations
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 36Population: Participants in the ITT-E Population (Induction Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.
A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=15 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
PAR with reduced abacavir susceptibility
|
0 participants
|
—
|
|
Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
PAR with reduced lamivudine susceptibility
|
1 participants
|
—
|
|
Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
PAR with reduced atazanavir susceptibility
|
0 participants
|
—
|
|
Number of Confirmed Virologic Failure Participants From Baseline Through Week 36 With Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
PAR with reduced ritonavir susceptibility
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Randomization at Week 36 through Week 84Population: Participants in the ITT-E population (Randomized Phase) who met the confirmed virologic failure (CVF) criteria with paired baseline and virologic failure phenotypic evaluations. One participant met CVF criteria at Week 36 and was randomized; these results are included in both the Week 36 and the Randomization through Week 84 results.
A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=1 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=7 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
PAR with reduced abacavir susceptibility
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
PAR with reduced lamivudine susceptibility
|
1 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
PAR with reduced atazanavir susceptibility
|
0 participants
|
0 participants
|
|
Number of Confirmed Virologic Failure Participants From Randomization at Week 36 Through Week 84 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
PAR with reduced ritonavir susceptibility
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 84 through Week 144Population: Participants in the ITT-Extension Population (Extension Phase) who met the confirmed virologic failure criteria with paired baseline and virologic failure phenotypic evaluations
A blood sample was drawn for participants failing to respond to therapy, and changes in drug susceptibility for HIV isolated from the participants for each drug used in the study were assessed. For each participant, the changes in drug susceptibility detected by phenotypic assay in virus from the sample collected at the time of failure was compared with drug susceptibility in the virus from the blood sample at baseline. PAR, participant.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=5 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=6 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
PAR with reduced lamivudine susceptibility
|
1 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
PAR with reduced abacavir susceptibility
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
PAR with reduced atazanavir susceptibility
|
0 participants
|
1 participants
|
|
Number of Confirmed Virologic Failure Participants From Week 84 Through Week 144 With Treatment-emergent Reductions in HIV Susceptibility to Abacavir, Lamivudine, Atazanavir, or Ritonavir
PAR with reduced ritonavir susceptibility
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 36Population: ITT-E Population, Induction Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.
Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=503 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Mean Percent Compliance at Week 36
Abacavir/Lamivudine
|
92.2 percent compliance
Standard Deviation 13.05
|
—
|
|
Mean Percent Compliance at Week 36
Ritonavir
|
92.3 percent compliance
Standard Deviation 12.15
|
—
|
|
Mean Percent Compliance at Week 36
Atazanavir
|
92.7 percent compliance
Standard Deviation 12.50
|
—
|
SECONDARY outcome
Timeframe: Week 84Population: ITT-E Population, Randomized Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.
Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=210 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=209 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Mean Percent Compliance at Week 84
Atazanavir
|
98.9 percent compliance
Standard Deviation 5.32
|
92.4 percent compliance
Standard Deviation 11.89
|
|
Mean Percent Compliance at Week 84
Abacavir/Lamivudine
|
92.0 percent compliance
Standard Deviation 11.62
|
91.2 percent compliance
Standard Deviation 13.49
|
|
Mean Percent Compliance at Week 84
Ritonavir
|
92.9 percent compliance
Standard Deviation 11.64
|
91.5 percent compliance
Standard Deviation 12.23
|
SECONDARY outcome
Timeframe: Week 144Population: ITT-Extension Population, Extension Phase. Participants with an unknown number of pills returned (including those whose pill bottles were not returned) were not included in this analysis.
Percent compliance is defined as the total number of pills taken divided by the total number of pills prescribed. The total number of pills taken was calculated by subtracting any returned pills from the total number of pills that were dispensed to each participant during this period. Compliance was calculated for each medication in the regimen.
Outcome measures
| Measure |
ABC/3TC + ATV: Randomized Phase
n=189 Participants
Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Randomized Phase
n=180 Participants
Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
|
|---|---|---|
|
Mean Percent Compliance at Week 144
Abacavir/Lamivudine
|
92.0 percent compliance
Standard Deviation 12.65
|
90.1 percent compliance
Standard Deviation 15.35
|
|
Mean Percent Compliance at Week 144
Ritonavir
|
93.3 percent compliance
Standard Deviation 11.07
|
90.1 percent compliance
Standard Deviation 14.58
|
|
Mean Percent Compliance at Week 144
Atazanavir
|
99.1 percent compliance
Standard Deviation 4.54
|
91.4 percent compliance
Standard Deviation 13.99
|
Adverse Events
ABC/3TC + ATV/r: Induction Phase
Serious events: 39 serious events
Other events: 237 other events
Deaths: 0 deaths
ABC/3TC + ATV: Randomization Phase
Serious events: 22 serious events
Other events: 116 other events
Deaths: 0 deaths
ABC/3TC + ATV/r: Randomization Phase
Serious events: 22 serious events
Other events: 123 other events
Deaths: 0 deaths
ABC/3TC + ATV: Extension Phase
Serious events: 24 serious events
Other events: 123 other events
Deaths: 0 deaths
ABC/3TC + ATV/r: Extension Phase
Serious events: 24 serious events
Other events: 130 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABC/3TC + ATV/r: Induction Phase
n=515 participants at risk
Induction Phase: participants in the Safety Population (participants exposed to at least one dose of investigational product) receiving abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
|
ABC/3TC + ATV: Randomization Phase
n=210 participants at risk
Randomization Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD; includes serious adverse events (SAEs) that occurred during induction phase
|
ABC/3TC + ATV/r: Randomization Phase
n=209 participants at risk
Randomization Phase: participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD; includes SAEs that occurred during induction phase
|
ABC/3TC + ATV: Extension Phase
n=189 participants at risk
Extension Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Extension Phase
n=180 participants at risk
participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
|
|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.58%
3/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.95%
2/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.1%
2/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Appendicitis, perforated
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.39%
2/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Pneumonia
|
0.39%
2/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Bronchitis
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.1%
2/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Cellulitis
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.95%
2/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.1%
4/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Shigella infection
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Gastroenteritis viral
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Lobar pneumonia
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Meningitis aseptic
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Proctitis gonococcal
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Sinusitis
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Staphylococcal infection
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Immune system disorders
Drug hypersensitivity
|
0.97%
5/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.95%
2/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.4%
3/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.2%
4/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Immune system disorders
Hypersensitivity
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Nervous system disorders
Convulsion
|
0.39%
2/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Syncope
|
0.39%
2/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.96%
2/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.1%
2/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Nervous system disorders
Headache
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Gastrointestinal disorders
Gastritis
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Gastrointestinal disorders
Nausea
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.1%
2/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Gastrointestinal disorders
Vomiting
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.1%
2/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Injury, poisoning and procedural complications
Fall
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Castleman's disease
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal neoplasm
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage II
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
General disorders
Chest pain
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.1%
2/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
General disorders
Pyrexia
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Psychiatric disorders
Depression
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Psychiatric disorders
Mental disorder
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Renal and urinary disorders
Renal failure
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Vascular disorders
Deep vein thrombosis
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Vascular disorders
Hypertensive crisis
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Eye disorders
Vision blurred
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
Other adverse events
| Measure |
ABC/3TC + ATV/r: Induction Phase
n=515 participants at risk
Induction Phase: participants in the Safety Population (participants exposed to at least one dose of investigational product) receiving abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
|
ABC/3TC + ATV: Randomization Phase
n=210 participants at risk
Randomization Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD; includes serious adverse events (SAEs) that occurred during induction phase
|
ABC/3TC + ATV/r: Randomization Phase
n=209 participants at risk
Randomization Phase: participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD; includes SAEs that occurred during induction phase
|
ABC/3TC + ATV: Extension Phase
n=189 participants at risk
Extension Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
|
ABC/3TC + ATV/r: Extension Phase
n=180 participants at risk
participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
|
|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.97%
5/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.9%
6/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.4%
3/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.8%
9/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.7%
3/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Influenza
|
1.7%
9/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.9%
6/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.9%
4/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.2%
6/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.3%
6/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.2%
42/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
11.4%
24/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
11.0%
23/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
13.2%
25/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
11.7%
21/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
7.8%
40/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
9.5%
20/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
10.5%
22/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
11.6%
22/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
13.3%
24/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.8%
30/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
6.7%
14/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
9.6%
20/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
7.4%
14/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
11.1%
20/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Gastrointestinal disorders
Nausea
|
4.7%
24/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
5.7%
12/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.8%
10/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.8%
9/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
6.7%
12/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
23/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.8%
10/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.3%
7/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
5.3%
10/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.9%
7/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Sinusitis
|
4.1%
21/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
7.1%
15/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
9.1%
19/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
10.1%
19/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
13.9%
25/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Bronchitis
|
3.5%
18/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
5.2%
11/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
10.5%
22/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
10.6%
20/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
12.2%
22/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Psychiatric disorders
Depression
|
3.5%
18/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
5.2%
11/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.8%
10/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
5.8%
11/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
8.3%
15/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Psychiatric disorders
Insomnia
|
3.3%
17/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.9%
6/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
5.3%
11/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
5.8%
11/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
7.2%
13/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Nervous system disorders
Headache
|
3.1%
16/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.8%
10/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.8%
10/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.8%
9/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
5.0%
9/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
16/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
6.2%
13/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
7.7%
16/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
10.6%
20/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
10.6%
19/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Psychiatric disorders
Anxiety
|
2.3%
12/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.3%
9/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.8%
8/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
5.3%
10/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.9%
7/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Investigations
Blood Cholesterol increased
|
1.6%
8/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.3%
7/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.3%
7/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.2%
8/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.9%
7/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
General disorders
Fatigue
|
0.78%
4/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.4%
5/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.8%
8/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.2%
6/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.4%
8/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Syphilis
|
1.4%
7/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.4%
5/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.3%
7/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
6.3%
12/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
5.6%
10/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Investigations
Lipase increased
|
0.78%
4/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.8%
8/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.8%
9/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.97%
5/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.3%
7/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
5.8%
11/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.7%
3/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
6/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.4%
3/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.4%
3/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.2%
8/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.3%
6/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
10/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.9%
6/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.4%
3/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.2%
8/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.8%
5/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Investigations
Blood triglycerides increased
|
1.6%
8/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.9%
4/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.9%
4/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.2%
6/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.3%
6/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.97%
5/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.9%
4/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.9%
4/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.6%
3/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.4%
8/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.78%
4/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.9%
6/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.4%
3/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.2%
6/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.2%
4/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Vascular disorders
Hypertension
|
0.19%
1/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.9%
4/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.1%
2/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.4%
8/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
7/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.95%
2/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.9%
6/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.1%
2/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
4.4%
8/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Eye disorders
Conjunctivitis
|
1.4%
7/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.4%
3/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.9%
4/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.6%
3/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.3%
6/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
9/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.9%
6/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.9%
4/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.2%
6/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.7%
3/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Investigations
Low density lipoprotein increased
|
0.78%
4/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.9%
4/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.4%
3/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.2%
6/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.1%
2/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.2%
6/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
2.4%
5/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.48%
1/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.2%
6/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.56%
1/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
|
Infections and infestations
Pneumonia
|
0.78%
4/515
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.00%
0/210
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
1.9%
4/209
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
0.53%
1/189
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
3.3%
6/180
Data are cumulative. If an adverse event (AE) occurs in the Induction Phase (IP) at \>=3%, and no new participants experience the AE in later phases, the participants who experienced the AE in the IP are carried over to the Randomization Phase and to the Extension Phase (if they remain in the study) if the incidence is \>=3% for at least one arm.
|
Additional Information
GSK Response Center
ViiV Healthcare
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER