Trial Outcomes & Findings for Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia (NCT NCT02420015)
NCT ID: NCT02420015
Last Updated: 2019-07-10
Results Overview
Prolonged abstinence will exclude tobacco use in the first two weeks following the quit date, as is consistent with other smoking cessation trials.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
35 participants
Primary outcome timeframe
6 month follow-up
Results posted on
2019-07-10
Participant Flow
One participant was deemed ineligible to participate in the study prior to randomization because that participant couldn't read or write English.
Participant milestones
| Measure |
iCOMMIT
Components include:
1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.
2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
3. 4 sessions cognitive-behavioral smoking cessation counseling;
4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.
5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.
|
Control Group
Components include:
1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
2. 4 sessions cognitive-behavioral smoking cessation counseling;
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
13
|
|
Overall Study
COMPLETED
|
21
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Health Technology to Enhance Abstinence in Smokers With Schizophrenia
Baseline characteristics by cohort
| Measure |
iCOMMIT
n=21 Participants
Components include:
1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.
2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
3. 4 sessions cognitive-behavioral smoking cessation counseling;
4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.
5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.
|
Control Group
n=13 Participants
Components include:
1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
2. 4 sessions cognitive-behavioral smoking cessation counseling;
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.24 years
STANDARD_DEVIATION 10.30 • n=5 Participants
|
46.92 years
STANDARD_DEVIATION 10.30 • n=7 Participants
|
48.39 years
STANDARD_DEVIATION 10.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
13 participants
n=7 Participants
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 month follow-upProlonged abstinence will exclude tobacco use in the first two weeks following the quit date, as is consistent with other smoking cessation trials.
Outcome measures
| Measure |
iCOMMIT
n=21 Participants
Components include:
1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.
2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
3. 4 sessions cognitive-behavioral smoking cessation counseling;
4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.
5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.
|
Control Group
n=13 Participants
Components include:
1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
2. 4 sessions cognitive-behavioral smoking cessation counseling;
|
|---|---|---|
|
Number of Participants Who Self-report Prolonged Abstinence
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 6 month follow-upSelf-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence at each follow-up.
Outcome measures
| Measure |
iCOMMIT
n=21 Participants
Components include:
1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.
2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
3. 4 sessions cognitive-behavioral smoking cessation counseling;
4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.
5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.
|
Control Group
n=13 Participants
Components include:
1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
2. 4 sessions cognitive-behavioral smoking cessation counseling;
|
|---|---|---|
|
Number of Participants Whose Prolonged Abstinence is Bio-verified
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 months post-quit attempt (Session 5)Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days.
Outcome measures
| Measure |
iCOMMIT
n=21 Participants
Components include:
1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.
2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
3. 4 sessions cognitive-behavioral smoking cessation counseling;
4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.
5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.
|
Control Group
n=13 Participants
Components include:
1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
2. 4 sessions cognitive-behavioral smoking cessation counseling;
|
|---|---|---|
|
Number of Participants Who Report 7 Day Point Prevalence Abstinence
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months post-quit attempt (Session 5)Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days.
Outcome measures
| Measure |
iCOMMIT
n=21 Participants
Components include:
1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.
2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
3. 4 sessions cognitive-behavioral smoking cessation counseling;
4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.
5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.
|
Control Group
n=13 Participants
Components include:
1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
2. 4 sessions cognitive-behavioral smoking cessation counseling;
|
|---|---|---|
|
Number of Participants Who Report 30 Day Point Prevalence Abstinence
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 months post-quit attempt (Session 6)Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days.
Outcome measures
| Measure |
iCOMMIT
n=21 Participants
Components include:
1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.
2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
3. 4 sessions cognitive-behavioral smoking cessation counseling;
4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.
5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.
|
Control Group
n=13 Participants
Components include:
1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
2. 4 sessions cognitive-behavioral smoking cessation counseling;
|
|---|---|---|
|
Number of Participants Who Report 7 Day Point Prevalence Abstinence
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 months post-quit attempt (Session 6)Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days.
Outcome measures
| Measure |
iCOMMIT
n=21 Participants
Components include:
1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.
2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
3. 4 sessions cognitive-behavioral smoking cessation counseling;
4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.
5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.
|
Control Group
n=13 Participants
Components include:
1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
2. 4 sessions cognitive-behavioral smoking cessation counseling;
|
|---|---|---|
|
Number of Participants Who Report 30 Day Point Prevalence Abstinence
|
1 Participants
|
2 Participants
|
Adverse Events
iCOMMIT
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Control Group
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
iCOMMIT
n=21 participants at risk
Components include:
1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.
2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
3. 4 sessions cognitive-behavioral smoking cessation counseling;
4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.
5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.
|
Control Group
n=13 participants at risk
Components include:
1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
2. 4 sessions cognitive-behavioral smoking cessation counseling;
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
9.5%
2/21 • Number of events 2 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
23.1%
3/13 • Number of events 4 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
Other adverse events
| Measure |
iCOMMIT
n=21 participants at risk
Components include:
1. mobile contingency management (mCM): Participants provide video recordings of themselves taking carbon monoxide readings to confirm smoking abstinence.
2. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
3. 4 sessions cognitive-behavioral smoking cessation counseling;
4. Stay Quit Coach: Stay Quit Coach is a smart phone application that provides support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment.
5. SMS text messaging: Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt.
|
Control Group
n=13 participants at risk
Components include:
1. pharmacotherapy for smoking cessation: Includes nicotine replacement therapy \[nicotine patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler)\] and bupropion (150 mg/daily for days 1-7 and 300 mg/daily thereafter)
2. 4 sessions cognitive-behavioral smoking cessation counseling;
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
14.3%
3/21 • Number of events 4 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
7.7%
1/13 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
General disorders
Mouth and/or throat irritation
|
14.3%
3/21 • Number of events 3 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
15.4%
2/13 • Number of events 2 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Social circumstances
Altercation with police
|
0.00%
0/21 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
7.7%
1/13 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Nervous system disorders
Jitteriness, shakiness
|
9.5%
2/21 • Number of events 2 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
7.7%
1/13 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Psychiatric disorders
Sleep problems and/or nightmares
|
14.3%
3/21 • Number of events 4 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
7.7%
1/13 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
9.5%
2/21 • Number of events 2 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
0.00%
0/13 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Skin and subcutaneous tissue disorders
Sweating
|
4.8%
1/21 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
0.00%
0/13 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Social circumstances
Family violence
|
9.5%
2/21 • Number of events 2 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
0.00%
0/13 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Social circumstances
Rape
|
0.00%
0/21 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
7.7%
1/13 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Psychiatric disorders
Increased psychiatric symptoms
|
4.8%
1/21 • Number of events 2 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
7.7%
1/13 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Gastrointestinal disorders
Nausea, upset stomach
|
9.5%
2/21 • Number of events 2 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
38.5%
5/13 • Number of events 5 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
General disorders
Flu
|
9.5%
2/21 • Number of events 2 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
7.7%
1/13 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Nervous system disorders
dizziness
|
4.8%
1/21 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
7.7%
1/13 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
7.7%
1/13 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.8%
1/21 • Number of events 2 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
0.00%
0/13 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Social circumstances
Car accident
|
4.8%
1/21 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
0.00%
0/13 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Social circumstances
Death in family
|
0.00%
0/21 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
7.7%
1/13 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Eye disorders
Eye infection
|
0.00%
0/21 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
7.7%
1/13 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Musculoskeletal and connective tissue disorders
Increased foot pain
|
4.8%
1/21 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
7.7%
1/13 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Respiratory, thoracic and mediastinal disorders
Benign tumor removed from lung
|
4.8%
1/21 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
0.00%
0/13 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Surgical and medical procedures
Dental surgery
|
4.8%
1/21 • Number of events 2 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
0.00%
0/13 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
General disorders
Pain
|
4.8%
1/21 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
0.00%
0/13 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Nervous system disorders
Increased seizures
|
4.8%
1/21 • Number of events 2 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
0.00%
0/13 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
|
Musculoskeletal and connective tissue disorders
Swelling in leg
|
0.00%
0/21 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
7.7%
1/13 • Number of events 1 • Data were collected for approximately nine months (from the baseline visit to the 6-month follow-up visit).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place