Trial Outcomes & Findings for Predictors and Consequences of Combustible Cigarette Smokers' Switch to Standardized Research E-Cigarettes (NCT NCT03277495)
NCT ID: NCT03277495
Last Updated: 2026-02-17
Results Overview
Number of cigarettes smoked per day in past week
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
12-weeks (end of treatment)
Results posted on
2026-02-17
Participant Flow
We screened 726 individuals and enrolled a sample of 63 smokers who completed the baseline questionnaire and started their first week of the ecological momentary assessment (EMA).
Randomization to the treatment arm occurred after participants completed the initial week of the EMA. Three individuals were dropped before randomization because of failure to complete and return the EMA data collection device and to return for the in-person visit. Sixty participants were thus randomized to the two treatment arms, with 30 randomized to the Usual Flavor condition and 30 to the Flavor Choice condition.
Participant milestones
| Measure |
Usual SREC Pods Flavor
The liquid in the e-cigarette refills contained nicotine and came in either tobacco or menthol. Participants in this condition received SREC pods in their usual cigarette flavor. Those who smoked menthol received only menthol pods and those who smoked regular cigarettes received tobacco pods.
|
Choice of SREC Pods Flavor
The liquid in the e-cigarette refills contained nicotine and came in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant received SREC pods in their choice of flavor.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
19
|
24
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
Reasons for withdrawal
| Measure |
Usual SREC Pods Flavor
The liquid in the e-cigarette refills contained nicotine and came in either tobacco or menthol. Participants in this condition received SREC pods in their usual cigarette flavor. Those who smoked menthol received only menthol pods and those who smoked regular cigarettes received tobacco pods.
|
Choice of SREC Pods Flavor
The liquid in the e-cigarette refills contained nicotine and came in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant received SREC pods in their choice of flavor.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Assessment Window Closed
|
6
|
2
|
Baseline Characteristics
Participants who completed the baseline visit prior to randomization
Baseline characteristics by cohort
| Measure |
Usual SREC Pods Flavor
n=32 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
|
Choice of SREC Pods Flavors
n=31 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=32 Participants • Participants who completed the baseline visit prior to randomization
|
16 Participants
n=31 Participants • Participants who completed the baseline visit prior to randomization
|
26 Participants
n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
Age, Continuous
|
42.06 years
STANDARD_DEVIATION 13.110 • n=32 Participants • Participants who completed the baseline visit prior to randomization
|
47.65 years
STANDARD_DEVIATION 10.757 • n=31 Participants • Participants who completed the baseline visit prior to randomization
|
44.81 years
STANDARD_DEVIATION 12.241 • n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
Sex: Female, Male
Female
|
12 Participants
n=32 Participants • Participants who completed the baseline visit prior to randomization
|
12 Participants
n=31 Participants • Participants who completed the baseline visit prior to randomization
|
24 Participants
n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
Sex: Female, Male
Male
|
20 Participants
n=32 Participants • Participants who completed the baseline visit prior to randomization
|
19 Participants
n=31 Participants • Participants who completed the baseline visit prior to randomization
|
39 Participants
n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=32 Participants • Participants who completed the baseline visit prior to randomization
|
0 Participants
n=31 Participants • Participants who completed the baseline visit prior to randomization
|
1 Participants
n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=32 Participants • Participants who completed the baseline visit prior to randomization
|
1 Participants
n=31 Participants • Participants who completed the baseline visit prior to randomization
|
5 Participants
n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=32 Participants • Participants who completed the baseline visit prior to randomization
|
0 Participants
n=31 Participants • Participants who completed the baseline visit prior to randomization
|
1 Participants
n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
Race (NIH/OMB)
White
|
15 Participants
n=32 Participants • Participants who completed the baseline visit prior to randomization
|
14 Participants
n=31 Participants • Participants who completed the baseline visit prior to randomization
|
29 Participants
n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=32 Participants • Participants who completed the baseline visit prior to randomization
|
0 Participants
n=31 Participants • Participants who completed the baseline visit prior to randomization
|
1 Participants
n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants • Participants who completed the baseline visit prior to randomization
|
0 Participants
n=31 Participants • Participants who completed the baseline visit prior to randomization
|
0 Participants
n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=32 Participants • Participants who completed the baseline visit prior to randomization
|
2 Participants
n=31 Participants • Participants who completed the baseline visit prior to randomization
|
8 Participants
n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=32 Participants • Participants who completed the baseline visit prior to randomization
|
28 Participants
n=31 Participants • Participants who completed the baseline visit prior to randomization
|
49 Participants
n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=32 Participants • Participants who completed the baseline visit prior to randomization
|
1 Participants
n=31 Participants • Participants who completed the baseline visit prior to randomization
|
6 Participants
n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
Combustible cigarette use
|
11.53 Number of cigarettes smoked per day
STANDARD_DEVIATION 7.112 • n=32 Participants • Anyone who completed the baseline visit prior to randomization
|
14.16 Number of cigarettes smoked per day
STANDARD_DEVIATION 16.906 • n=31 Participants • Anyone who completed the baseline visit prior to randomization
|
12.83 Number of cigarettes smoked per day
STANDARD_DEVIATION 12.858 • n=63 Participants • Anyone who completed the baseline visit prior to randomization
|
|
Abstinence
|
0 Participants
n=32 Participants • Participants who completed the baseline visit prior to randomization
|
0 Participants
n=31 Participants • Participants who completed the baseline visit prior to randomization
|
0 Participants
n=63 Participants • Participants who completed the baseline visit prior to randomization
|
|
CO level
|
16.38 ppm
STANDARD_DEVIATION 11.085 • n=32 Participants • Anyone who completed the baseline visit prior to randomization
|
22.71 ppm
STANDARD_DEVIATION 17.086 • n=31 Participants • Anyone who completed the baseline visit prior to randomization
|
19.49 ppm
STANDARD_DEVIATION 14.591 • n=63 Participants • Anyone who completed the baseline visit prior to randomization
|
|
Blood Pressure - Systolic
|
115.8281 mm hg
STANDARD_DEVIATION 17.971 • n=32 Participants • Anyone who completed the baseline visit prior to randomization
|
116.9500 mm hg
STANDARD_DEVIATION 20.582 • n=31 Participants • Anyone who completed the baseline visit prior to randomization
|
116.37 mm hg
STANDARD_DEVIATION 19.127 • n=63 Participants • Anyone who completed the baseline visit prior to randomization
|
|
Blood Pressure - Diastolic
|
75.4063 mm hg
STANDARD_DEVIATION 13.288 • n=32 Participants • Anyone who completed the baseline visit prior to randomization
|
78.2667 mm hg
STANDARD_DEVIATION 15.048 • n=31 Participants • Anyone who completed the baseline visit prior to randomization
|
76.79 mm hg
STANDARD_DEVIATION 14.122 • n=63 Participants • Anyone who completed the baseline visit prior to randomization
|
|
Heart Rate
|
73.6720 Beats per minute
STANDARD_DEVIATION 12.85723 • n=31 Participants • Participants who completed the baseline visit and heart rate was collected N = 31 Usual SREC pods Flavor; N = 30 Choice of SREC pods Flavors. Missing cases were attributed equipment malfunction or participant refusal.
|
77.6889 Beats per minute
STANDARD_DEVIATION 13.96347 • n=30 Participants • Participants who completed the baseline visit and heart rate was collected N = 31 Usual SREC pods Flavor; N = 30 Choice of SREC pods Flavors. Missing cases were attributed equipment malfunction or participant refusal.
|
75.65 Beats per minute
STANDARD_DEVIATION 13.45 • n=61 Participants • Participants who completed the baseline visit and heart rate was collected N = 31 Usual SREC pods Flavor; N = 30 Choice of SREC pods Flavors. Missing cases were attributed equipment malfunction or participant refusal.
|
|
Weight
|
170.56 pounds
STANDARD_DEVIATION 45.820 • n=32 Participants • Anyone who completed the baseline visit prior to randomization
|
193.81 pounds
STANDARD_DEVIATION 54.718 • n=31 Participants • Anyone who completed the baseline visit prior to randomization
|
182.00 pounds
STANDARD_DEVIATION 51.339 • n=63 Participants • Anyone who completed the baseline visit prior to randomization
|
|
nicotine dependence
|
6.2 scores on a scale
STANDARD_DEVIATION 1.57268 • n=32 Participants • Anyone who completed the baseline visit prior to randomization
|
5.8682 scores on a scale
STANDARD_DEVIATION 1.28633 • n=31 Participants • Anyone who completed the baseline visit prior to randomization
|
6.0341 scores on a scale
STANDARD_DEVIATION 1.42974 • n=63 Participants • Anyone who completed the baseline visit prior to randomization
|
|
self-report of respiratory symptoms
|
3.5078 scores on a scale
STANDARD_DEVIATION 2.22566 • n=32 Participants • Anyone who completed the baseline visit prior to randomization
|
3.1210 scores on a scale
STANDARD_DEVIATION 1.99465 • n=31 Participants • Anyone who completed the baseline visit prior to randomization
|
3.3175 scores on a scale
STANDARD_DEVIATION 2.10711 • n=63 Participants • Anyone who completed the baseline visit prior to randomization
|
PRIMARY outcome
Timeframe: 12-weeks (end of treatment)Population: All participants who received at least one dose of SREC and completed the EOT visit at Week 14
Number of cigarettes smoked per day in past week
Outcome measures
| Measure |
Usual SREC Pods Flavor
n=19 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
|
Choice of SREC Pods Flavors
n=22 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
|
|---|---|---|
|
Combustible Cigarette Use
|
3.79 Number of cigarettes smoked per day
Standard Deviation 4.637
|
3.64 Number of cigarettes smoked per day
Standard Deviation 4.598
|
SECONDARY outcome
Timeframe: 12-weeks (end of treatment)Population: All participants who received at least one dose of SREC and completed the EOT visit at Week 14
The proportion of participants who achieve total abstinence from combustible cigarettes (defined as no cigarette smoking in the past 7 days)
Outcome measures
| Measure |
Usual SREC Pods Flavor
n=19 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
|
Choice of SREC Pods Flavors
n=22 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
|
|---|---|---|
|
Abstinence
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 18-weeks (end of trial)Population: All participants who completed the follow up period at Week 18
Average 7-day cigarette rate
Outcome measures
| Measure |
Usual SREC Pods Flavor
n=19 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
|
Choice of SREC Pods Flavors
n=22 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
|
|---|---|---|
|
Number of Cigarettes Smoked
|
7.73 Number of cigarettes
Standard Deviation 7.165
|
5.93 Number of cigarettes
Standard Deviation 3.872
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-weeksPopulation: All participants who received at least one dose of SREC and completed the EOT visit at Week 14
CO level in ppm
Outcome measures
| Measure |
Usual SREC Pods Flavor
n=19 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
|
Choice of SREC Pods Flavors
n=22 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
|
|---|---|---|
|
CO Level
|
9.58 ppm
Standard Deviation 10.469
|
10.05 ppm
Standard Deviation 12.512
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-weeksPopulation: All participants who received at least one dose of SREC and completed the EOT visit at Week 14
Mean systolic blood pressure in mm hg
Outcome measures
| Measure |
Usual SREC Pods Flavor
n=19 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
|
Choice of SREC Pods Flavors
n=22 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
|
|---|---|---|
|
Blood Pressure - Systolic
|
120.18 mm hg
Standard Deviation 15.129
|
120.84 mm hg
Standard Deviation 13.668
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-weeksPopulation: All participants who received at least one dose of SREC and completed the EOT visit at Week 14
Mean diastolic blood pressure in mm hg
Outcome measures
| Measure |
Usual SREC Pods Flavor
n=19 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
|
Choice of SREC Pods Flavors
n=22 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
|
|---|---|---|
|
Blood Pressure - Diastolic
|
79.44 mm hg
Standard Deviation 12.588
|
77.83 mm hg
Standard Deviation 10.571
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-weeksPopulation: All participants who received at least one dose of SREC and completed the EOT visit at Week 14
beats per minute
Outcome measures
| Measure |
Usual SREC Pods Flavor
n=19 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
|
Choice of SREC Pods Flavors
n=20 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
|
|---|---|---|
|
Heart Rate
|
80.1140 Beats per minute
Standard Deviation 12.78044
|
77.1167 Beats per minute
Standard Deviation 10.58468
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-weeksPopulation: All participants who received at least one dose of SREC and completed the EOT visit at Week 14
in pounds
Outcome measures
| Measure |
Usual SREC Pods Flavor
n=19 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
|
Choice of SREC Pods Flavors
n=21 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
|
|---|---|---|
|
Weight
|
175.53 pounds
Standard Deviation 34.539
|
196.86 pounds
Standard Deviation 68.425
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-weeksPopulation: All participants who received at least one dose of SREC and completed the EOT visit at Week 14
Self-reported respiratory health was measured by computing the average of four items designed to assess severity of respiratory symptoms including: cough, phlegm production, shortness of breath, and irritation in throat and lungs. Participants rated each symptom on a scale from 1 (None) to 10 (Severe) with higher total scores indicating more severe respiratory health problems.
Outcome measures
| Measure |
Usual SREC Pods Flavor
n=19 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
|
Choice of SREC Pods Flavors
n=22 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
|
|---|---|---|
|
Self-report of Respiratory Symptoms
|
2.5789 scores on a scale
Standard Deviation 1.51853
|
1.6250 scores on a scale
Standard Deviation 0.76279
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-weeksPopulation: All participants who received at least one dose of SREC and completed the EOT visit at Week 14
Nicotine dependence was measured using the Fagerstrom Test for Nicotine Dependence (FTND). Total scores calculated using the sum of six items and can range from 0 to 12 with higher scores indicating higher nicotine dependence.
Outcome measures
| Measure |
Usual SREC Pods Flavor
n=19 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
|
Choice of SREC Pods Flavors
n=22 Participants
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
|
|---|---|---|
|
Nicotine Dependence
|
4.23 scores on a scale
Standard Deviation 2.421
|
3.53 scores on a scale
Standard Deviation 2.183
|
Adverse Events
Usual SREC Pods Flavor
Serious events: 1 serious events
Other events: 17 other events
Deaths: 1 deaths
Choice of SREC Pods Flavors
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual SREC Pods Flavor
n=30 participants at risk
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
|
Choice of SREC Pods Flavors
n=30 participants at risk
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
|
|---|---|---|
|
Endocrine disorders
Hospitalization
|
0.00%
0/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
3.3%
1/30 • Number of events 1 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
|
General disorders
Hospitalization
|
0.00%
0/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
3.3%
1/30 • Number of events 1 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
3.3%
1/30 • Number of events 1 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
0.00%
0/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
Other adverse events
| Measure |
Usual SREC Pods Flavor
n=30 participants at risk
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor.
|
Choice of SREC Pods Flavors
n=30 participants at risk
The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
3/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
3.3%
1/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.7%
11/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
36.7%
11/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
23.3%
7/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
16.7%
5/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
|
Nervous system disorders
Headache
|
20.0%
6/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
23.3%
7/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
|
Gastrointestinal disorders
Throat problems
|
16.7%
5/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
26.7%
8/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
5/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
10.0%
3/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
|
Gastrointestinal disorders
Mouth Problems
|
16.7%
5/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
0.00%
0/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
|
General disorders
Dizziness
|
10.0%
3/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
10.0%
3/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
|
Nervous system disorders
Sweating
|
6.7%
2/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
6.7%
2/30 • From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place