Trial Outcomes & Findings for Quit Smoking Study for People Who Use E-Cigarettes (NCT NCT04946825)
NCT ID: NCT04946825
Last Updated: 2025-05-22
Results Overview
The investigators will report breath carbon monoxide (CO; \<6 ppm) confirmed 7-day point-prevalence abstinence from combustible cigarettes at the end of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
396 participants
Primary outcome timeframe
End of treatment (ie., the 3 month follow up)
Results posted on
2025-05-22
Participant Flow
Participant milestones
| Measure |
Quit Cigarettes, But Continue Using E-cigarettes, With Nicotine Replacement Therapy and Text Support
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Nicotine Replacement Therapy and Text Support.
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
|
Quit Cigarettes, But Continue Using E-cigarettes, With Text Support.
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Text Support.
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
96
|
102
|
102
|
96
|
|
Overall Study
COMPLETED
|
73
|
86
|
77
|
75
|
|
Overall Study
NOT COMPLETED
|
23
|
16
|
25
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quit Smoking Study for People Who Use E-Cigarettes
Baseline characteristics by cohort
| Measure |
Quit Cigarettes, But Continue Using E-cigarettes, With Nicotine Replacement Therapy and Text Support
n=96 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Nicotine Replacement Therapy and Text Support.
n=102 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
|
Quit Cigarettes, But Continue Using E-cigarettes, With Text Support.
n=102 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Text Support.
n=96 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25.8 Years
STANDARD_DEVIATION 2.5 • n=99 Participants
|
25.6 Years
STANDARD_DEVIATION 2.8 • n=107 Participants
|
26.4 Years
STANDARD_DEVIATION 2.2 • n=206 Participants
|
26.2 Years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
26.0 Years
STANDARD_DEVIATION 2.5 • n=31 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
209 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
187 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
44 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
68 Participants
n=7 Participants
|
291 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
34 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
55 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
85 Participants
n=7 Participants
|
341 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: End of treatment (ie., the 3 month follow up)Population: Breath carbon monoxide (CO) data were unavailable for the majority of participants due to a software malfunction with the app used to remotely transmit data from the CoVita iCO Smokerlyzer devices.
The investigators will report breath carbon monoxide (CO; \<6 ppm) confirmed 7-day point-prevalence abstinence from combustible cigarettes at the end of treatment.
Outcome measures
| Measure |
Quit Cigarettes, But Continue Using E-cigarettes, With Nicotine Replacement Therapy and Text Support
n=51 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Nicotine Replacement Therapy and Text Support.
n=52 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
|
Quit Cigarettes, But Continue Using E-cigarettes, With Text Support.
n=57 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Text Support.
n=61 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
|
|---|---|---|---|---|
|
Biochemically Confirmed 7-day Point-prevalence Cigarette Abstinence
|
16 Participants
|
26 Participants
|
16 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: End of treatment (ie., the 3 month follow up)The investigators will report self-reported 7-day point-prevalence abstinence from combustible cigarettes at the end of treatment.
Outcome measures
| Measure |
Quit Cigarettes, But Continue Using E-cigarettes, With Nicotine Replacement Therapy and Text Support
n=96 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Nicotine Replacement Therapy and Text Support.
n=102 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
|
Quit Cigarettes, But Continue Using E-cigarettes, With Text Support.
n=102 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Text Support.
n=96 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
|
|---|---|---|---|---|
|
Self-reported 7-day Point-prevalence Cigarette Abstinence
|
44 Participants
|
56 Participants
|
40 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: The 3 month treatment period.Total number of participants who reported any adverse event during the 3-month treatment period.
Outcome measures
| Measure |
Quit Cigarettes, But Continue Using E-cigarettes, With Nicotine Replacement Therapy and Text Support
n=96 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Nicotine Replacement Therapy and Text Support.
n=102 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
|
Quit Cigarettes, But Continue Using E-cigarettes, With Text Support.
n=102 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Text Support.
n=96 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
|
|---|---|---|---|---|
|
Adverse Events During Treatment
|
7 Participants
|
11 Participants
|
8 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: The 3-month follow up (ie., end of treatment)Population: Breath carbon monoxide (CO) data were unavailable for the majority of participants due to a software malfunction with the app used to remotely transmit data from the CoVita iCO Smokerlyzer devices.
The investigators will report CO confirmed 30-day prolonged abstinence from combustible cigarettes at the 3 month follow up.
Outcome measures
| Measure |
Quit Cigarettes, But Continue Using E-cigarettes, With Nicotine Replacement Therapy and Text Support
n=51 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Nicotine Replacement Therapy and Text Support.
n=52 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
|
Quit Cigarettes, But Continue Using E-cigarettes, With Text Support.
n=57 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Text Support.
n=61 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
|
|---|---|---|---|---|
|
Biochemically Confirmed Prolonged 30-day Abstinence
|
10 Participants
|
21 Participants
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: The 3-month follow up (ie., end of treatment) and 6-month follow up (3 months after the end of treatment).The investigators will report self-reported 30-day prolonged abstinence from combustible cigarettes at the 3- and 6-month follow ups.
Outcome measures
| Measure |
Quit Cigarettes, But Continue Using E-cigarettes, With Nicotine Replacement Therapy and Text Support
n=96 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Nicotine Replacement Therapy and Text Support.
n=102 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
|
Quit Cigarettes, But Continue Using E-cigarettes, With Text Support.
n=102 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Text Support.
n=96 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
|
|---|---|---|---|---|
|
Self-reported Prolonged 30-day Abstinence
3-month follow-up
|
27 Participants
|
48 Participants
|
31 Participants
|
28 Participants
|
|
Self-reported Prolonged 30-day Abstinence
6-month follow-up
|
44 Participants
|
43 Participants
|
38 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: The 3-month treatment period.The investigators will report the percent of participants who made a quit attempt lasting any length of time (including very short quit attempts) during treatment.
Outcome measures
| Measure |
Quit Cigarettes, But Continue Using E-cigarettes, With Nicotine Replacement Therapy and Text Support
n=96 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Nicotine Replacement Therapy and Text Support.
n=102 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
|
Quit Cigarettes, But Continue Using E-cigarettes, With Text Support.
n=102 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Text Support.
n=96 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
|
|---|---|---|---|---|
|
Any Attempts to Quit Combustible Cigarettes
|
89 Participants
|
100 Participants
|
92 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: The 3-month treatment period.Population: This analysis is limited to the subset of participants who reported continued smoking at the 3-month follow-up.
The investigators will report cigarettes per day during the 3 month treatment period among participants who continue to smoke cigarettes.
Outcome measures
| Measure |
Quit Cigarettes, But Continue Using E-cigarettes, With Nicotine Replacement Therapy and Text Support
n=29 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Nicotine Replacement Therapy and Text Support.
n=30 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
|
Quit Cigarettes, But Continue Using E-cigarettes, With Text Support.
n=37 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Text Support.
n=33 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
|
|---|---|---|---|---|
|
Cigarettes Per Day
|
4.67 Cigarettes per day during the prior week
Standard Deviation 6.05
|
4.67 Cigarettes per day during the prior week
Standard Deviation 4.75
|
4.37 Cigarettes per day during the prior week
Standard Deviation 5.32
|
4.84 Cigarettes per day during the prior week
Standard Deviation 5.37
|
SECONDARY outcome
Timeframe: The 3-month treatment period.Population: This analysis is limited to the subset of participants who reported continued smoking at the 3-month follow-up.
The investigators will report cigarette dependence using the Patient Reported Outcomes Measurement Information System (PROMIS) measure of cigarette dependence (total score of 0=least to 4=most dependent) during the 3 month treatment period among participants who continue to smoke cigarettes.
Outcome measures
| Measure |
Quit Cigarettes, But Continue Using E-cigarettes, With Nicotine Replacement Therapy and Text Support
n=29 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Nicotine Replacement Therapy and Text Support.
n=30 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
|
Quit Cigarettes, But Continue Using E-cigarettes, With Text Support.
n=37 Participants
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Text Support.
n=33 Participants
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
|
|---|---|---|---|---|
|
Cigarette Dependence
|
1.78 Scores on a scale
Standard Deviation 1.30
|
1.71 Scores on a scale
Standard Deviation 1.14
|
1.58 Scores on a scale
Standard Deviation 1.10
|
1.70 Scores on a scale
Standard Deviation 1.22
|
Adverse Events
Quit Cigarettes, But Continue Using E-cigarettes, With Nicotine Replacement Therapy and Text Support
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Quit Cigarettes and Quit E-cigarettes With Nicotine Replacement Therapy and Text Support.
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Quit Cigarettes, But Continue Using E-cigarettes, With Text Support.
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Quit Cigarettes and Quit E-cigarettes With Text Support.
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quit Cigarettes, But Continue Using E-cigarettes, With Nicotine Replacement Therapy and Text Support
n=96 participants at risk
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Nicotine Replacement Therapy and Text Support.
n=102 participants at risk
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
|
Quit Cigarettes, But Continue Using E-cigarettes, With Text Support.
n=102 participants at risk
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Quit Cigarettes and Quit E-cigarettes With Text Support.
n=96 participants at risk
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.00%
0/96 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.98%
1/102 • Number of events 1 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
2.0%
2/102 • Number of events 2 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.00%
0/96 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
|
Infections and infestations
Infections and infestations
|
0.00%
0/96 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.00%
0/102 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.00%
0/102 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
1.0%
1/96 • Number of events 1 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
|
Nervous system disorders
Nervous system disorders
|
1.0%
1/96 • Number of events 1 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.98%
1/102 • Number of events 1 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.98%
1/102 • Number of events 1 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
1.0%
1/96 • Number of events 1 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, pueperium and perinatal conditions
|
1.0%
1/96 • Number of events 1 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.00%
0/102 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.00%
0/102 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.00%
0/96 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
|
Psychiatric disorders
Psychiatric disorders
|
2.1%
2/96 • Number of events 3 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
8.8%
9/102 • Number of events 9 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
3.9%
4/102 • Number of events 4 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
7.3%
7/96 • Number of events 7 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
2.1%
2/96 • Number of events 2 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.00%
0/102 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.98%
1/102 • Number of events 1 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
3.1%
3/96 • Number of events 3 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
1.0%
1/96 • Number of events 1 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.00%
0/102 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.00%
0/102 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
0.00%
0/96 • Adverse events were collected over the 3-month treatment period.
All participants were asked if they experienced one or more adverse events on each weekly survey during the 3-month treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place