Trial Outcomes & Findings for BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated. (NCT NCT00931801)
NCT ID: NCT00931801
Last Updated: 2017-07-21
Results Overview
To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA \< 40 copies/mL.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
43 participants
Primary outcome timeframe
48 weeks
Results posted on
2017-07-21
Participant Flow
Recruitment was initiated on 15 APR 2010 and enrolled subjects through 31 JAN 2011. Recruitment and screening took place at 10 participating sites (9 medical clinics and 1 clinical research organization). 43 subjects were enrolled.
There were 7 participants that did not meet eligibility criteria (either due to disallowed concomitant medication use or safety labs outside of the required parameters). 2 of those 7 subjects re-screened at a later date and were confirmed eligible. 2 subjects withdrew consent after the screening visit but prior to starting the assigned treatment.
Participant milestones
| Measure |
Control Arm
atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
|
Intervention Arm No.1
atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
|
Intervention Arm No.2
atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
14
|
|
Overall Study
COMPLETED
|
13
|
14
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
Control Arm
atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
|
Intervention Arm No.1
atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
|
Intervention Arm No.2
atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Confirmed Virologic Failure
|
0
|
0
|
3
|
Baseline Characteristics
BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated.
Baseline characteristics by cohort
| Measure |
Control Arm
n=14 Participants
atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
|
Intervention Arm No.1
n=15 Participants
atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
|
Intervention Arm No.2
n=14 Participants
atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
46.6 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
45.9 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
14 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Mean CD4
|
544.6 cells/mm3
STANDARD_DEVIATION 197.7 • n=5 Participants
|
518.5 cells/mm3
STANDARD_DEVIATION 198.9 • n=7 Participants
|
533.9 cells/mm3
STANDARD_DEVIATION 198.3 • n=5 Participants
|
532.0 cells/mm3
STANDARD_DEVIATION 193.8 • n=4 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: All enrolled participants were included in this analysis of primary outcome measurement.
To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA \< 40 copies/mL.
Outcome measures
| Measure |
Control Arm
n=14 Participants
Continue baseline regimen of atazanavir/ritonavir 300/100mg once daily plus tenofovir and emtricitabine
|
Intervention Arm No.1
n=15 Participants
switch to atazanavir/ritonavir 300/100mg once daily plus raltegravir 400mg twice daily
|
Intervention Arm No.2
n=14 Participants
switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
|
Total
All study arms combined
|
|---|---|---|---|---|
|
Maintenance of Virologic Suppression
Virologic Response
|
13 participants
|
14 participants
|
10 participants
|
—
|
|
Maintenance of Virologic Suppression
Confirmed Virologic Failures
|
0 participants
|
0 participants
|
3 participants
|
—
|
|
Maintenance of Virologic Suppression
Withdrawal Due to AE; HIV RNA < 50 copies/mL
|
0 participants
|
0 participants
|
1 participants
|
—
|
|
Maintenance of Virologic Suppression
Other Withdrawal; HIV RNA < 50 copies/mL
|
1 participants
|
1 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Values included for all enrolled participants excluding participants with confirmed virologic failure or those missing values due to early withdrawal, loss to follow-up or lab error.
Change in mean CD4 from Baseline to Week 48.
Outcome measures
| Measure |
Control Arm
n=12 Participants
Continue baseline regimen of atazanavir/ritonavir 300/100mg once daily plus tenofovir and emtricitabine
|
Intervention Arm No.1
n=14 Participants
switch to atazanavir/ritonavir 300/100mg once daily plus raltegravir 400mg twice daily
|
Intervention Arm No.2
n=10 Participants
switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
|
Total
n=36 Participants
All study arms combined
|
|---|---|---|---|---|
|
The Difference in CD4 From Baseline to Week 48
CD4 at Baseline
|
535.8 cells/mm3
Standard Deviation 210.9
|
514.1 cells/mm3
Standard Deviation 205.7
|
539.1 cells/mm3
Standard Deviation 206.2
|
528.3 cells/mm3
Standard Deviation 201.9
|
|
The Difference in CD4 From Baseline to Week 48
CD4 at Week 48
|
611.2 cells/mm3
Standard Deviation 218.1
|
526.3 cells/mm3
Standard Deviation 210.5
|
507.2 cells/mm3
Standard Deviation 201.7
|
549.3 cells/mm3
Standard Deviation 209.5
|
|
The Difference in CD4 From Baseline to Week 48
CD4 Change
|
75.4 cells/mm3
Standard Deviation 133.9
|
12.1 cells/mm3
Standard Deviation 96.4
|
-31.9 cells/mm3
Standard Deviation 122.0
|
21.0 cells/mm3
Standard Deviation 121.5
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Values included for all enrolled participants excluding participants with confirmed virologic failure or those missing values due to early withdrawal, loss to follow-up or other error.
Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.
Outcome measures
| Measure |
Control Arm
n=12 Participants
Continue baseline regimen of atazanavir/ritonavir 300/100mg once daily plus tenofovir and emtricitabine
|
Intervention Arm No.1
n=13 Participants
switch to atazanavir/ritonavir 300/100mg once daily plus raltegravir 400mg twice daily
|
Intervention Arm No.2
n=10 Participants
switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
|
Total
n=35 Participants
All study arms combined
|
|---|---|---|---|---|
|
The Change in Adherence to Study Treatment Arm From Baseline to Week 48
3 Day Adherence Recall at Baseline
|
100 percentage of prescribed doses
Standard Deviation 0
|
97.5 percentage of prescribed doses
Standard Deviation 9.2
|
96.7 percentage of prescribed doses
Standard Deviation 10.4
|
98.1 percentage of prescribed doses
Standard Deviation 7.8
|
|
The Change in Adherence to Study Treatment Arm From Baseline to Week 48
3 Day Adherence Recall at Week 48
|
100 percentage of prescribed doses
Standard Deviation 0
|
97.5 percentage of prescribed doses
Standard Deviation 9.2
|
95.0 percentage of prescribed doses
Standard Deviation 15.8
|
97.6 percentage of prescribed doses
Standard Deviation 10
|
|
The Change in Adherence to Study Treatment Arm From Baseline to Week 48
Change in 3 Day Adherence Recall
|
0 percentage of prescribed doses
Standard Deviation 0
|
0 percentage of prescribed doses
Standard Deviation 13.5
|
-1.7 percentage of prescribed doses
Standard Deviation 19.9
|
-0.5 percentage of prescribed doses
Standard Deviation 13
|
SECONDARY outcome
Timeframe: baseline and 48 weeksPopulation: Data for all participants assigned to a study treatment was analyzed except data for participants that did not have both baseline and week 48 data, including early withdrawal, virologic failure, loss to follow-up or missing data.
Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment.
Outcome measures
| Measure |
Control Arm
n=11 Participants
Continue baseline regimen of atazanavir/ritonavir 300/100mg once daily plus tenofovir and emtricitabine
|
Intervention Arm No.1
n=12 Participants
switch to atazanavir/ritonavir 300/100mg once daily plus raltegravir 400mg twice daily
|
Intervention Arm No.2
n=8 Participants
switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
|
Total
n=31 Participants
All study arms combined
|
|---|---|---|---|---|
|
Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
Mean Quality of Life Score at Baseline
|
92.9 units on a scale
Standard Deviation 8.6
|
77.4 units on a scale
Standard Deviation 16.1
|
82.5 units on a scale
Standard Deviation 11.6
|
84.2 units on a scale
Standard Deviation 14.1
|
|
Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
Mean Quality of Life Score at Week 48
|
90.5 units on a scale
Standard Deviation 11.1
|
78.2 units on a scale
Standard Deviation 22.6
|
81.3 units on a scale
Standard Deviation 17.5
|
83.3 units on a scale
Standard Deviation 18.2
|
|
Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
Change in Quality of Life
|
-2.5 units on a scale
Standard Deviation 8.2
|
0.8 units on a scale
Standard Deviation 20.0
|
-1.3 units on a scale
Standard Deviation 12.7
|
-0.9 units on a scale
Standard Deviation 14.4
|
Adverse Events
Control Arm
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Intervention Arm No.1
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Intervention Arm No.2
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Total
Serious events: 5 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Arm
n=14 participants at risk
Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
|
Intervention Arm No.1
n=15 participants at risk
switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
|
Intervention Arm No.2
n=14 participants at risk
switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
|
Total
n=43 participants at risk
All study arms combined
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization due to asthma
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Psychiatric disorders
Hospitalization for Recurrent Depression
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
Other adverse events
| Measure |
Control Arm
n=14 participants at risk
Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
|
Intervention Arm No.1
n=15 participants at risk
switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
|
Intervention Arm No.2
n=14 participants at risk
switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
|
Total
n=43 participants at risk
All study arms combined
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
hypertophy of tonsils
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Blood and lymphatic system disorders
lymphadenopathy
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Cardiac disorders
chest pain
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Cardiac disorders
ECG changes
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Cardiac disorders
hypertension
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Cardiac disorders
palpitations without chest pain
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Ear and labyrinth disorders
eustacian tube dysfunction
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Endocrine disorders
hypogonadism
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Eye disorders
visual disturbance
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Eye disorders
vitreous detachment
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
abdominal pain
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
apthous ulcer
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
changes to bowel movements
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
constipation
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
dental pain
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/14 • 48 Weeks
|
20.0%
3/15 • Number of events 3 • 48 Weeks
|
21.4%
3/14 • Number of events 3 • 48 Weeks
|
14.0%
6/43 • Number of events 6 • 48 Weeks
|
|
Gastrointestinal disorders
dry throat
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
dyspepsia
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
feeling full upon awakening
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
7.0%
3/43 • Number of events 3 • 48 Weeks
|
|
Gastrointestinal disorders
GI disturbance
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
gingivitis
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
heart burn
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Gastrointestinal disorders
Pharyngitis
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
11.6%
5/43 • Number of events 5 • 48 Weeks
|
|
Gastrointestinal disorders
tooth abscess
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
7.0%
3/43 • Number of events 3 • 48 Weeks
|
|
General disorders
Nightsweats
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
General disorders
Thirst
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
General disorders
weight gain
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Infections and infestations
conjunctivitis
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Infections and infestations
influenza like illness
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Infections and infestations
latent mycobacterium tuberculosis Infection
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Infections and infestations
scabies
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Infections and infestations
Sinusitis
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Infections and infestations
STI
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
13.3%
2/15 • Number of events 2 • 48 Weeks
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
11.6%
5/43 • Number of events 5 • 48 Weeks
|
|
Injury, poisoning and procedural complications
bone fracture
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Injury, poisoning and procedural complications
facial laceration
|
0.00%
0/14 • 48 Weeks
|
13.3%
2/15 • Number of events 2 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Injury, poisoning and procedural complications
leg pain
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Musculoskeletal and connective tissue disorders
gout
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Musculoskeletal and connective tissue disorders
lower back pain
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Musculoskeletal and connective tissue disorders
lower extremity ache
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Musculoskeletal and connective tissue disorders
lower extremity pain
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Musculoskeletal and connective tissue disorders
popliteal cyst
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
20.0%
3/15 • Number of events 3 • 48 Weeks
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
14.0%
6/43 • Number of events 6 • 48 Weeks
|
|
Nervous system disorders
insomnia
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
7.0%
3/43 • Number of events 3 • 48 Weeks
|
|
Nervous system disorders
light headedness
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Nervous system disorders
paresthesias
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Nervous system disorders
vivid dreams
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Psychiatric disorders
Depression
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
9.3%
4/43 • Number of events 4 • 48 Weeks
|
|
Renal and urinary disorders
Dysuria
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Renal and urinary disorders
Renal Calculus
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Renal and urinary disorders
Urinary Tract Infection
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
13.3%
2/15 • Number of events 2 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
9.3%
4/43 • Number of events 4 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/14 • 48 Weeks
|
20.0%
3/15 • Number of events 3 • 48 Weeks
|
7.1%
1/14 • Number of events 2 • 48 Weeks
|
9.3%
4/43 • Number of events 5 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Pressure
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Congestion
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
7.0%
3/43 • Number of events 3 • 48 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 2 • 48 Weeks
|
21.4%
3/14 • Number of events 3 • 48 Weeks
|
9.3%
4/43 • Number of events 5 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Abscess
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
6.7%
1/15 • Number of events 2 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
7.0%
3/43 • Number of events 4 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Angular Chelitis
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Cutaneous Sarcoidosis, worsening
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Groin Itch
|
0.00%
0/14 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
loose nails - bilateral halux
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
2.3%
1/43 • Number of events 1 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin Rash, unspecified
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
9.3%
4/43 • Number of events 4 • 48 Weeks
|
|
Skin and subcutaneous tissue disorders
Tinea Cruris
|
0.00%
0/14 • 48 Weeks
|
0.00%
0/15 • 48 Weeks
|
14.3%
2/14 • Number of events 2 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
|
Social circumstances
Substance Misuse
|
7.1%
1/14 • Number of events 1 • 48 Weeks
|
6.7%
1/15 • Number of events 1 • 48 Weeks
|
0.00%
0/14 • 48 Weeks
|
4.7%
2/43 • Number of events 2 • 48 Weeks
|
Additional Information
Calvin J. Cohen MD, MSc, Director of Research
Community Research Initiative of New England
Phone: 617-502-1700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place