Trial Outcomes & Findings for Metabolism Informed Smoking Treatment: The MIST RCT (NCT NCT04590404)
NCT ID: NCT04590404
Last Updated: 2025-12-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
606 participants
Primary outcome timeframe
6 months
Results posted on
2025-12-05
Participant Flow
Participants were recruited from a tertiary care hospital in the US Mid-South from November 17, 2020 to September 29, 2023.
5 participants were removed pre-randomization assignment by PI due to new information, discovered post-consent, indicating ineligibility.
Participant milestones
| Measure |
MIST (Metabolism-Informed Smoking Treatment)
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR \<0.31-NRT).
|
Guideline-Based Care
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results.
|
|---|---|---|
|
Overall Study
STARTED
|
294
|
307
|
|
Overall Study
1-month Survey
|
259
|
271
|
|
Overall Study
3-month Survey
|
246
|
264
|
|
Overall Study
6-month Survey
|
247
|
261
|
|
Overall Study
12-month Survey
|
235
|
246
|
|
Overall Study
COMPLETED
|
271
|
288
|
|
Overall Study
NOT COMPLETED
|
23
|
19
|
Reasons for withdrawal
| Measure |
MIST (Metabolism-Informed Smoking Treatment)
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR \<0.31-NRT).
|
Guideline-Based Care
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results.
|
|---|---|---|
|
Overall Study
Death
|
16
|
17
|
|
Overall Study
Withdrawal by Subject
|
7
|
2
|
Baseline Characteristics
Metabolism Informed Smoking Treatment: The MIST RCT
Baseline characteristics by cohort
| Measure |
MIST (Metabolism-Informed Smoking Treatment)
n=294 Participants
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR \<0.31-NRT).
|
Guideline-Based Care
n=307 Participants
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results.
|
Total
n=601 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=74 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
231 Participants
n=37 Participants
|
220 Participants
n=37 Participants
|
451 Participants
n=74 Participants
|
|
Age, Categorical
>=65 years
|
63 Participants
n=37 Participants
|
87 Participants
n=37 Participants
|
150 Participants
n=74 Participants
|
|
Age, Continuous
|
55.88 years
STANDARD_DEVIATION 11.60 • n=37 Participants
|
56.45 years
STANDARD_DEVIATION 11.53 • n=37 Participants
|
56.17 years
STANDARD_DEVIATION 11.56 • n=74 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=37 Participants
|
136 Participants
n=37 Participants
|
263 Participants
n=74 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=37 Participants
|
171 Participants
n=37 Participants
|
338 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=37 Participants
|
4 Participants
n=37 Participants
|
9 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
287 Participants
n=37 Participants
|
300 Participants
n=37 Participants
|
587 Participants
n=74 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=37 Participants
|
3 Participants
n=37 Participants
|
5 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
2 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
2 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=37 Participants
|
0 Participants
n=37 Participants
|
2 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
58 Participants
n=37 Participants
|
66 Participants
n=37 Participants
|
124 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
White
|
224 Participants
n=37 Participants
|
239 Participants
n=37 Participants
|
463 Participants
n=74 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
7 Participants
n=37 Participants
|
1 Participants
n=37 Participants
|
8 Participants
n=74 Participants
|
|
Region of Enrollment
United States
|
294 participants
n=37 Participants
|
307 participants
n=37 Participants
|
601 participants
n=74 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Randomized participants were analyzed. Participants with missing self-report or biochemical verification data were assumed to be smoking (missing=smoking).
Outcome measures
| Measure |
MIST (Metabolism-Informed Smoking Treatment)
n=294 Participants
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR \<0.31-NRT).
|
Guideline-Based Care
n=307 Participants
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results.
|
|---|---|---|
|
Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
|
54 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Randomized participants were analyzed. Participants with missing self-report or biochemical verification data were assumed to be smoking (missing=smoking).
Outcome measures
| Measure |
MIST (Metabolism-Informed Smoking Treatment)
n=294 Participants
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR \<0.31-NRT).
|
Guideline-Based Care
n=307 Participants
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results.
|
|---|---|---|
|
Biochemically-validated Past 7-day Point Prevalence Tobacco Abstinence
|
49 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: 1, 3 monthsParticipants taking any stop-smoking medications in past 7 days at 1 AND/OR 3 month surveys, also includes those who reported completing their course of medication at 3 months.
Outcome measures
| Measure |
MIST (Metabolism-Informed Smoking Treatment)
n=294 Participants
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR \<0.31-NRT).
|
Guideline-Based Care
n=307 Participants
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results.
|
|---|---|---|
|
Self-reported Medication Adherence Over the Past 7 Days
|
234 Participants
|
232 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months after hospital dischargePopulation: Of note, 395 participants were missing for this measure due to report of not having an office visit and/or non-completion of all follow-up surveys.
Randomized participants who reported having an office visit with PCP or regular healthcare provider and reported receiving a medication recommendation or prescription (since study enrollment; 1, 3, 6, or 12 months). Some participants may have reported receiving more than 1 prescription over the course of the 12 months.
Outcome measures
| Measure |
MIST (Metabolism-Informed Smoking Treatment)
n=294 Participants
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR \<0.31-NRT).
|
Guideline-Based Care
n=307 Participants
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results.
|
|---|---|---|
|
Self-reported Receipt of Prescription for Smoking Cessation Medication Subsequent to the Initial Study Medication Prescription
|
70 Participants
|
74 Participants
|
Adverse Events
MIST (Metabolism-Informed Smoking Treatment)
Serious events: 140 serious events
Other events: 84 other events
Deaths: 16 deaths
Guideline-Based Care
Serious events: 131 serious events
Other events: 90 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
MIST (Metabolism-Informed Smoking Treatment)
n=294 participants at risk
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR \<0.31-NRT).
|
Guideline-Based Care
n=307 participants at risk
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results.
|
|---|---|---|
|
Psychiatric disorders
Anxiety (includes nervousness and panic attacks)
|
0.68%
2/294 • Number of events 2 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
2.0%
6/307 • Number of events 7 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/294 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
2.3%
7/307 • Number of events 7 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Cardiac disorders
Emergency Medical Visit
|
3.1%
9/294 • Number of events 11 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
2.9%
9/307 • Number of events 10 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Surgical and medical procedures
Emergency Medical Visit
|
24.8%
73/294 • Number of events 159 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
24.8%
76/307 • Number of events 175 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Product Issues
Medication Side Effects
|
1.0%
3/294 • Number of events 3 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
0.00%
0/307 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Cardiac disorders
Scheduled Medical Procedure
|
1.7%
5/294 • Number of events 5 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
0.98%
3/307 • Number of events 3 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Investigations
Scheduled Medical Procedure
|
0.34%
1/294 • Number of events 1 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
0.00%
0/307 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Renal and urinary disorders
Hospital Admission
|
1.4%
4/294 • Number of events 8 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
2.6%
8/307 • Number of events 8 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Surgical and medical procedures
Scheduled Medical Procedure
|
8.8%
26/294 • Number of events 34 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
10.1%
31/307 • Number of events 36 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Blood and lymphatic system disorders
Hospital Admission
|
0.68%
2/294 • Number of events 2 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
0.00%
0/307 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Cardiac disorders
Hospital Admission
|
5.4%
16/294 • Number of events 18 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
4.2%
13/307 • Number of events 15 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Endocrine disorders
Hospital Admission
|
0.00%
0/294 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
0.33%
1/307 • Number of events 1 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Gastrointestinal disorders
Hospital Admission
|
0.68%
2/294 • Number of events 2 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
0.00%
0/307 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
General disorders
Hospital Admission
|
0.00%
0/294 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
0.65%
2/307 • Number of events 2 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Hepatobiliary disorders
Hospital Admission
|
0.00%
0/294 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
0.65%
2/307 • Number of events 2 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Infections and infestations
Hospital Admission
|
2.4%
7/294 • Number of events 8 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
1.6%
5/307 • Number of events 5 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Injury, poisoning and procedural complications
Hospital Admission
|
0.68%
2/294 • Number of events 2 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
0.65%
2/307 • Number of events 2 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Investigations
Hospital Admission
|
0.00%
0/294 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
0.33%
1/307 • Number of events 1 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospital Admission
|
0.68%
2/294 • Number of events 2 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
0.00%
0/307 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Respiratory, thoracic and mediastinal disorders
Hospital Admission
|
1.0%
3/294 • Number of events 3 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
0.33%
1/307 • Number of events 1 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Skin and subcutaneous tissue disorders
Hospital Admission
|
0.00%
0/294 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
0.33%
1/307 • Number of events 1 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Surgical and medical procedures
Hospital Admission
|
8.8%
26/294 • Number of events 28 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
5.5%
17/307 • Number of events 19 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
Other adverse events
| Measure |
MIST (Metabolism-Informed Smoking Treatment)
n=294 participants at risk
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. The MIST intervention used NMR to select medication (Fast Metabolizers NMR≥0.31-varenicline; Slow Metabolizers NMR \<0.31-NRT).
|
Guideline-Based Care
n=307 participants at risk
All patients had a tobacco treatment consult and NMR measured by LC-tandem mass spectroscopy before randomization; all received 3 months of medication (varenicline or combination nicotine replacement therapy (NRT)) and access to tobacco counseling. Medication was selected by shared decision making. Guideline-based care participants were not informed of NMR results.
|
|---|---|---|
|
General disorders
Fatigue
|
6.5%
19/294 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
9.8%
30/307 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
General disorders
Insomnia
|
10.9%
32/294 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
9.4%
29/307 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
General disorders
Agitation and/or irritability
|
4.1%
12/294 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
5.9%
18/307 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Psychiatric disorders
Anxiety (includes nervousness and panic attacks)
|
5.1%
15/294 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
6.8%
21/307 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
General disorders
Restlessness
|
5.1%
15/294 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
7.2%
22/307 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
|
Nervous system disorders
Headaches
|
4.8%
14/294 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
5.2%
16/307 • 12 months
Other (non-serious) AEs are restricted to those that participants initially self-reported as "Severe" on follow-up surveys and were determined to be non-serious by PI review.
|
Additional Information
Dr. Hilary Tindle
Vanderbilt University Medical Center
Phone: (615) 875-9726
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place