Trial Outcomes & Findings for Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder (NCT NCT00118534)
NCT ID: NCT00118534
Last Updated: 2014-05-05
Results Overview
The primary outcome measure was 12-month bio-verified prolonged abstinence from tobacco between 6 and 18 months postrandomization. Prolonged abstinence excluded tobacco use before 6 months postrandomization. Prolonged abstinence defined non-abstinence as 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks. Self-reported prolonged abstinence was verified by exhaled CO ≤ 8ppm and urine cotinine \<100 ng/mL cotinine equivalents at the 9-18 month visits. If CO or cotinine was missing, a single measure was used for verification. If both CO and cotinine were missing at any visit between 9 and 15 months, patients reporting prolonged abstinence were considered abstinent if all other available bioverification data confirmed abstinence. Patients who lacked CO and cotinine readings at 18 months or failed to attend the 18 month visit were considered nonabstinent.
COMPLETED
NA
943 participants
between 6 and 18 months
2014-05-05
Participant Flow
Recruitment occurred between November 2004 and December 2007, with follow-up continuing until July 2009.943 patients were recruited from outpatient PTSD clinics at 10 VA medical centers and followed up for a minimum of 18 months.
Patients gave written informed consent before enrollment.
Participant milestones
| Measure |
Integrated Care
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
472
|
471
|
|
Overall Study
COMPLETED
|
472
|
471
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Integrating Clinical Practice Guidelines for Smoking Cessation Into Mental Health Care for Veterans With Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
Total
n=943 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 years
n=5 Participants
|
54.7 years
n=7 Participants
|
54.56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
444 Participants
n=5 Participants
|
439 Participants
n=7 Participants
|
883 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
472 participants
n=5 Participants
|
471 participants
n=7 Participants
|
943 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: between 6 and 18 monthsThe primary outcome measure was 12-month bio-verified prolonged abstinence from tobacco between 6 and 18 months postrandomization. Prolonged abstinence excluded tobacco use before 6 months postrandomization. Prolonged abstinence defined non-abstinence as 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks. Self-reported prolonged abstinence was verified by exhaled CO ≤ 8ppm and urine cotinine \<100 ng/mL cotinine equivalents at the 9-18 month visits. If CO or cotinine was missing, a single measure was used for verification. If both CO and cotinine were missing at any visit between 9 and 15 months, patients reporting prolonged abstinence were considered abstinent if all other available bioverification data confirmed abstinence. Patients who lacked CO and cotinine readings at 18 months or failed to attend the 18 month visit were considered nonabstinent.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
Bioverified 12-Month Prolonged Abstinence Between 6 and 18 Months Postrandomization
|
42 participants
|
21 participants
|
SECONDARY outcome
Timeframe: between 6 and 18 monthsA secondary outcome was self-reported 1-year prolonged abstinence between 6 and 18 months post-randomization. Prolonged abstinence excluded tobacco use prior to 6 months post-randomization to allow for initial treatment episode completion and recovery from early relapses. Prolonged abstinence defined non-abstinence as: 1) smoking for 7 consecutive days or at least once a week for 2 consecutive weeks, or 2) using non-cigarette tobacco for 7 consecutive days or at least once a week for 2 consecutive weeks.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
Self-reported 12-month Prolonged Abstinence Between 6 and 18 Months
|
73 participants
|
33 participants
|
SECONDARY outcome
Timeframe: Baseline and 18 monthsSeverity of PTSD was a predetermined secondary outcome. One of the measurements for this was CAPS at 18 months. The range is 0-136; five rationally derived severity score ranges for interpreting CAPS total score have been proposed and are as follows: 0-19 = asymptomatic/few symptoms, 20-39 = mild PTSD/subthreshold, 40-59 = moderate PTSD/threshold, 60-79 = severe PTSD symptomatology, and \>80 = extreme PTSD symptomology. A rationally derived 15-point change in CAPS total severity score has been proposed as a marker of clinically significant change. The above severity ranges and 15-point marker are preliminary (Frank W. Weathers et. al., "Clinician-administered PTSD Scale: A Review of the First Ten Years of Research", Depression and Anxiety 13: 132-156 (2001)). The results are reported in mean change from baseline.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
Clinician Administered PTSD Scale (CAPS)
|
-7.2 Units on a scale
Interval -9.1 to -5.2
|
-7.0 Units on a scale
Interval -9.0 to -5.0
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsSeverity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
PTSD Checklist
|
-2.0 units on a scale
Interval -3.0 to -1.0
|
-0.9 units on a scale
Interval -1.9 to 0.2
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsSeverity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
PTSD Checklist
|
1.6 units on a scale
Interval 0.5 to 2.7
|
2.2 units on a scale
Interval 1.1 to 3.3
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsSeverity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
PTSD Checklist
|
-1.4 units on a scale
Interval -2.5 to -0.4
|
-0.9 units on a scale
Interval -2.0 to 0.2
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsSeverity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
PTSD Checklist
|
-1.6 units on a scale
Interval -2.7 to -0.5
|
-1.4 units on a scale
Interval -2.5 to -0.3
|
SECONDARY outcome
Timeframe: Baseline and 15 monthsSeverity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
PTSD Checklist
|
-1.8 units on a scale
Interval -2.9 to -0.8
|
-0.9 units on a scale
Interval -2.0 to 0.2
|
SECONDARY outcome
Timeframe: Baseline and 18 monthsSeverity of PTSD was a predetermined secondary outcome. One of the measurements for this was PTSD Checklist (range, 17-85; scores of greater or equal to 50 indicate a PTSD diagnosis) at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
PTSD Checklist
|
-3.2 units on a scale
Interval -4.3 to -2.1
|
-2.4 units on a scale
Interval -3.5 to -1.2
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsThe Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 3 month assessment.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
|
0.6 units on a scale
Interval 0.1 to 1.0
|
0.9 units on a scale
Interval 0.4 to 1.4
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsThe Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 6 month assessment.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
|
0.9 units on a scale
Interval 0.3 to 1.4
|
1.0 units on a scale
Interval 0.4 to 1.5
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsThe Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 9 month assessment.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
|
1.1 units on a scale
Interval 0.6 to 1.7
|
1.3 units on a scale
Interval 0.7 to 1.9
|
SECONDARY outcome
Timeframe: Baseline and 12 monthsThe Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 12 month assessment.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
|
1.6 units on a scale
Interval 1.0 to 2.1
|
1.2 units on a scale
Interval 0.6 to 1.8
|
SECONDARY outcome
Timeframe: Baseline and 15 monthsThe Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 15 month assessment.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
|
1.1 units on a scale
Interval 0.6 to 1.6
|
1.2 units on a scale
Interval 0.6 to 1.8
|
SECONDARY outcome
Timeframe: Baseline and 18 monthsThe Patient Health Questionnaire 9 (PHQ-9; range, 0-27; scores of 10-14, 15-19, and greater than or equal to 20 indicate mild, moderate, and severe depression,respectively) measured depression at every assessment. The results are reported as the mean change from baseline for the 18 month assessment.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
|
-0.2 units on a scale
Interval -0.7 to 0.4
|
-0.3 units on a scale
Interval -0.8 to 0.3
|
SECONDARY outcome
Timeframe: 3 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
7-day Point Prevalence Abstinence - Self Reported
|
126 participants
Interval 107.0 to 145.0
|
65 participants
Interval 50.0 to 80.0
|
SECONDARY outcome
Timeframe: 6 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
7-day Point Prevalence Abstinence - Self Reported
|
132 participants
Interval 113.0 to 151.0
|
63 participants
Interval 49.0 to 77.0
|
SECONDARY outcome
Timeframe: 9 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
7-day Point Prevalence Abstinence - Self Reported
|
122 participants
Interval 103.0 to 141.0
|
60 participants
Interval 46.0 to 74.0
|
SECONDARY outcome
Timeframe: 12 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
7-day Point Prevalence Abstinence - Self Reported
|
117 participants
Interval 99.0 to 135.0
|
70 participants
Interval 55.0 to 85.0
|
SECONDARY outcome
Timeframe: 15 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
7-day Point Prevalence Abstinence - Self Reported
|
119 participants
Interval 101.0 to 137.0
|
63 participants
Interval 49.0 to 77.0
|
SECONDARY outcome
Timeframe: 18 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
7-day Point Prevalence Abstinence - Self Reported
|
111 participants
Interval 93.0 to 129.0
|
73 participants
Interval 58.0 to 88.0
|
SECONDARY outcome
Timeframe: 3 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
7-day Point Prevalence Abstinence - Bio-Verified
|
67 participants
Interval 52.0 to 82.0
|
37 participants
Interval 26.0 to 48.0
|
SECONDARY outcome
Timeframe: 6 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
7-day Point Prevalence Abstinence - Bio-Verified
|
78 participants
Interval 62.0 to 94.0
|
34 participants
Interval 23.0 to 45.0
|
SECONDARY outcome
Timeframe: 9 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
7-day Point Prevalence Abstinence - Bio-Verified
|
70 participants
Interval 55.0 to 85.0
|
35 participants
Interval 24.0 to 46.0
|
SECONDARY outcome
Timeframe: 12 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
7-day Point Prevalence Abstinence - Bio-Verified
|
66 participants
Interval 51.0 to 81.0
|
44 participants
Interval 32.0 to 56.0
|
SECONDARY outcome
Timeframe: 15 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
7-day Point Prevalence Abstinence - Bio-Verified
|
67 participants
Interval 52.0 to 82.0
|
36 participants
Interval 25.0 to 47.0
|
SECONDARY outcome
Timeframe: 18 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
7-day Point Prevalence Abstinence - Bio-Verified
|
86 participants
Interval 70.0 to 102.0
|
51 participants
Interval 38.0 to 64.0
|
SECONDARY outcome
Timeframe: 3 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
30-day Point Prevalence Abstinence - Self Reported
|
126 participants
Interval 107.0 to 145.0
|
65 participants
Interval 50.0 to 80.0
|
SECONDARY outcome
Timeframe: 6 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
30-day Point Prevalence Abstinence - Self Reported
|
132 participants
Interval 113.0 to 151.0
|
63 participants
Interval 49.0 to 77.0
|
SECONDARY outcome
Timeframe: 9 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
30-day Point Prevalence Abstinence - Self Reported
|
122 participants
Interval 103.0 to 141.0
|
60 participants
Interval 46.0 to 74.0
|
SECONDARY outcome
Timeframe: 12 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
30-day Point Prevalence Abstinence - Self Reported
|
117 participants
Interval 99.0 to 135.0
|
70 participants
Interval 55.0 to 85.0
|
SECONDARY outcome
Timeframe: 15 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
30-day Point Prevalence Abstinence - Self Reported
|
119 participants
Interval 101.0 to 137.0
|
63 participants
Interval 49.0 to 77.0
|
SECONDARY outcome
Timeframe: 18 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
30-day Point Prevalence Abstinence - Self Reported
|
111 participants
Interval 93.0 to 129.0
|
73 participants
Interval 58.0 to 88.0
|
SECONDARY outcome
Timeframe: 3 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
30-day Point Prevalence Abstinence - Bio-Verified
|
67 participants
Interval 52.0 to 82.0
|
37 participants
Interval 26.0 to 48.0
|
SECONDARY outcome
Timeframe: 6 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
30-day Point Prevalence Abstinence - Bio-Verified
|
78 participants
Interval 62.0 to 94.0
|
34 participants
Interval 23.0 to 45.0
|
SECONDARY outcome
Timeframe: 9 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
30-day Point Prevalence Abstinence - Bio-Verified
|
70 participants
Interval 55.0 to 85.0
|
35 participants
Interval 24.0 to 46.0
|
SECONDARY outcome
Timeframe: 12 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
30-day Point Prevalence Abstinence - Bio-Verified
|
66 participants
Interval 51.0 to 81.0
|
44 participants
Interval 32.0 to 56.0
|
SECONDARY outcome
Timeframe: 15 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
30-day Point Prevalence Abstinence - Bio-Verified
|
67 participants
Interval 52.0 to 82.0
|
36 participants
Interval 25.0 to 47.0
|
SECONDARY outcome
Timeframe: 18 monthsPredetermined secondary smoking outcomes included 7- and 30-day point prevalence abstinence at each assessment, where abstinence was defined as no tobacco use in the prior 7 or 30 days, respectively. Self-reported point prevalence abstinence was determined for all patients, with patients not completing a visit presumed to be nonabstinent. Exhaled carbon monoxide (CO) was obtained at every in person assessment. Urine cotinine levels, using Accutest® NicAlert™ test strips, were ascertained at assessments when patients self-reported no use of tobacco or nicotine replacement therapy in the prior 7 days. Laboratory assays of urine cotinine were obtained when self-reported abstinence disagreed with NicAlert™ results. If bioverification data were missing or did not confirm abstinence, patients were considered nonabstinent at that visit.
Outcome measures
| Measure |
Integrated Care
n=472 Participants
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 Participants
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
30-day Point Prevalence Abstinence - Bio-Verified
|
86 participants
Interval 70.0 to 102.0
|
51 participants
Interval 38.0 to 64.0
|
Adverse Events
Integrated Care
Standard of Care
Serious adverse events
| Measure |
Integrated Care
n=472 participants at risk
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 participants at risk
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
General disorders
Unevaluable event
|
1.7%
8/472 • Number of events 9
|
1.7%
8/471 • Number of events 10
|
|
Cardiac disorders
AV nodal reentrant tachycardia
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Cardiac disorders
Angina attack
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.21%
1/472 • Number of events 1
|
0.64%
3/471 • Number of events 3
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Cardiac disorders
Atrial flutter
|
0.64%
3/472 • Number of events 4
|
0.21%
1/471 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Cardiac disorders
Chest pain - cardiac
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Cardiac disorders
Congestive cardiac failure aggravated
|
0.21%
1/472 • Number of events 2
|
0.21%
1/471 • Number of events 2
|
|
Cardiac disorders
Congestive heart failure
|
0.85%
4/472 • Number of events 6
|
0.42%
2/471 • Number of events 2
|
|
Cardiac disorders
Constrictive pericarditis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.85%
4/472 • Number of events 4
|
1.9%
9/471 • Number of events 11
|
|
Cardiac disorders
Coronary artery occlusion
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Cardiac disorders
Coronary artery stenosis
|
0.21%
1/472 • Number of events 2
|
0.00%
0/471
|
|
Cardiac disorders
Coronary occlusion
|
0.21%
1/472 • Number of events 2
|
0.00%
0/471
|
|
Cardiac disorders
Heart attack
|
0.42%
2/472 • Number of events 2
|
0.42%
2/471 • Number of events 2
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
8/472 • Number of events 10
|
0.42%
2/471 • Number of events 2
|
|
Cardiac disorders
Non STEMI
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Cardiac disorders
Non-Q wave MI
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Cardiac disorders
Non-ischemic cardiomyopathy
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Cardiac disorders
Paroxysmal supraventricular tachycardia
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Cardiac disorders
Right heart failure
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Cardiac disorders
Unstable angina
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Cardiac disorders
Ventricular fibrillation
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Cardiac disorders
Ventricular tachycardia
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Congenital, familial and genetic disorders
Arteriovenous malformations
|
0.00%
0/472
|
0.21%
1/471 • Number of events 2
|
|
Congenital, familial and genetic disorders
Maxillary hypoplasia
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Eye disorders
Alternating exotropia
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Eye disorders
Cataract
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Eye disorders
Diplopia
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Eye disorders
Macular degeneration
|
0.00%
0/472
|
0.21%
1/471 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Gastrointestinal disorders
Achalasia
|
0.21%
1/472 • Number of events 2
|
0.00%
0/471
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 2
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Gastrointestinal disorders
Bleeding duodenal ulcer
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Bleeding gastric ulcer
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Blood in stool
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Chronic pancreatitis
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Gastrointestinal disorders
Constipation
|
0.42%
2/472 • Number of events 2
|
0.64%
3/471 • Number of events 3
|
|
Gastrointestinal disorders
Constipation chronic
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Crohn's disease
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Gastrointestinal disorders
GERD
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Gastrointestinal disorders
GI bleed
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
GI tract bleed
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Gastrointestinal disorders
Left lower quadrant pain
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Gastrointestinal disorders
Nausea
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.64%
3/472 • Number of events 3
|
0.00%
0/471
|
|
Gastrointestinal disorders
Perforated colon
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Persistent vomiting
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Rectal disorder
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Gastrointestinal disorders
Right inguinal hernia
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Gastrointestinal disorders
Upper abdominal pain
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Uvulitis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/472
|
0.42%
2/471 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting blood
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting post chemotherapy
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
General disorders
Chest pain
|
1.3%
6/472 • Number of events 6
|
1.7%
8/471 • Number of events 9
|
|
General disorders
Cyst
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
General disorders
Death NOS
|
0.42%
2/472 • Number of events 2
|
0.42%
2/471 • Number of events 2
|
|
General disorders
Died in sleep
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
General disorders
Disease complication
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
General disorders
Edema
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
General disorders
Edema of lower extremities
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
General disorders
Hernia
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
General disorders
Non-cardiac chest pain
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
General disorders
Opiate withdrawal symptoms
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
General disorders
Ulcer
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Hepatobiliary disorders
Cholecystitis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Hepatobiliary disorders
Gallbladder pain
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Hepatobiliary disorders
Gallbladder stones
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Hepatobiliary disorders
Obstructive jaundice
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Abdominal abscess
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Abscess intestinal
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Abscess limb
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Abscess on buttock
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Acute appendicitis
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Infections and infestations
Acute bronchitis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Appendicitis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Appendicitis perforated
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Asymptomatic neurosyphilis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Bacterial meningitis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Breast abscess
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Cellulitis
|
0.64%
3/472 • Number of events 3
|
0.64%
3/471 • Number of events 3
|
|
Infections and infestations
Cellulitis of arm
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Cellulitis of leg
|
0.21%
1/472 • Number of events 1
|
0.42%
2/471 • Number of events 3
|
|
Infections and infestations
Clostridium difficile colitis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Community acquired pneumonia
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Condyloma
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Creutzfeldt-Jakob disease
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Diabetic foot infection
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Diverticulitis
|
0.85%
4/472 • Number of events 5
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Ear infection
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Ear infection viral
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
HIV infection
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Infections and infestations
Hip osteomyelitis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Infection urinary tract
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Legionnaire's disease
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Lyme disease
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
MRSA wound infection
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Methicillin-resistant staphylococcal aureus infection
|
0.00%
0/472
|
0.42%
2/471 • Number of events 3
|
|
Infections and infestations
Mouth abscess
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Nasal abscess
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Neurosyphilis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Osteomyelitis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Pharyngitis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Infections and infestations
Pneumonia
|
1.3%
6/472 • Number of events 6
|
1.9%
9/471 • Number of events 9
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Postoperative wound infection
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Respiratory infection
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Sialadenitis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Infections and infestations
Spinal osteomyelitis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Surgical wound infection
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
UTI
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Infections and infestations
Viral gastroenteritis
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Infections and infestations
Viral hepatitis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Viral pneumonia
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Achilles tendon injury
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Acute alcoholic intoxication
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Alcohol intoxication
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Automobile accident
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Broken leg
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Cat bite
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Coronary stent occlusion
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Crushing injury of trunk
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cycling accident
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Delayed recovery from anesthetic
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Dumping syndrome
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.64%
3/472 • Number of events 3
|
1.9%
9/471 • Number of events 10
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Fractured ribs
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Implant failure
|
0.42%
2/472 • Number of events 3
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Implantable defibrillator malfunction
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Injury, poisoning and procedural complications
Laceration
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Medication error
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
0.21%
1/472 • Number of events 1
|
0.85%
4/471 • Number of events 4
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Overdose
|
0.42%
2/472 • Number of events 2
|
0.64%
3/471 • Number of events 3
|
|
Injury, poisoning and procedural complications
Overdose effect
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Post biopsy bleeding
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Post procedural bleeding
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Postoperative complication
|
0.21%
1/472 • Number of events 6
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Postoperative hypotension
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Rupture tendon
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spider bite
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Injury, poisoning and procedural complications
Sports injury
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Injury, poisoning and procedural complications
Suture granuloma
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Investigations
Biopsy larynx normal
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Investigations
Blood carbon monoxide increased
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Investigations
Blood sugar increased
|
0.21%
1/472 • Number of events 1
|
0.42%
2/471 • Number of events 2
|
|
Investigations
Cardiac catheterization
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Investigations
Coronary angiogram
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Investigations
Elevated prostate specific antigen [PSA]
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Investigations
Weight gain
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.85%
4/472 • Number of events 4
|
0.00%
0/471
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.21%
1/472 • Number of events 2
|
0.21%
1/471 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.21%
1/472 • Number of events 1
|
0.42%
2/471 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium deficiency
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Metabolism and nutrition disorders
Type II diabetes mellitus
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Metabolism and nutrition disorders
Unspecified nutritional deficiency
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Complete rupture of rotator cuff
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
"Degeneration of intervertebral disc, site unspecified"
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
Degenerative joint disease
|
0.42%
2/472 • Number of events 2
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
Herniated disc
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.42%
2/472 • Number of events 2
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
Lumbar disc degeneration
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar disc herniation
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.21%
1/472 • Number of events 1
|
0.42%
2/471 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in arm
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff injury
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff tear
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
Shoulder bursitis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of kidney
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of prostate
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the prostate recurrent
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.42%
2/472 • Number of events 4
|
0.42%
2/471 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder carcinoma
|
0.00%
0/472
|
0.21%
1/471 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.21%
1/472 • Number of events 3
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast ductal carcinoma
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma hepatocellular
|
0.42%
2/472 • Number of events 2
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Esophageal adenocarcinoma lower third in situ
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Esophageal cancer
|
0.00%
0/472
|
0.42%
2/471 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.85%
4/472 • Number of events 5
|
0.85%
4/471 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant hepatic neoplasm
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
"Malignant neoplasm of colon, unspecified"
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic disease
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.42%
2/472 • Number of events 3
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral carcinoma in situ
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic adenocarcinoma
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic cancer
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary adenoma
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate adenoma
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.3%
6/472 • Number of events 7
|
1.1%
5/471 • Number of events 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage II
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.42%
2/472 • Number of events 2
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal clear cell carcinoma
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.42%
2/472 • Number of events 4
|
0.21%
1/471 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma of the bladder stage unspecified
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Nervous system disorders
Benign essential tremor
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Nervous system disorders
Carotid artery stenosis
|
0.64%
3/472 • Number of events 4
|
0.00%
0/471
|
|
Nervous system disorders
Cerebrovascular accident
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Nervous system disorders
Cervical myelopathy
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Nervous system disorders
Cervical radiculopathy
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Nervous system disorders
Diabetic coma
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Nervous system disorders
Drug-induced encephalopathy
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Nervous system disorders
Forehead headache
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Nervous system disorders
Headache
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/472
|
0.21%
1/471 • Number of events 3
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.21%
1/472 • Number of events 1
|
0.42%
2/471 • Number of events 2
|
|
Nervous system disorders
Migraine
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Nervous system disorders
Myelitis transverse
|
0.00%
0/472
|
0.21%
1/471 • Number of events 2
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Nervous system disorders
Oversedation
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Nervous system disorders
Radiculopathy
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Nervous system disorders
Seizure
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Nervous system disorders
Seizures
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Nervous system disorders
Simple partial seizures
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Nervous system disorders
Stroke
|
0.42%
2/472 • Number of events 2
|
0.42%
2/471 • Number of events 3
|
|
Nervous system disorders
Syncope
|
0.64%
3/472 • Number of events 3
|
0.42%
2/471 • Number of events 2
|
|
Nervous system disorders
Transient ischaemic attack
|
0.42%
2/472 • Number of events 2
|
0.21%
1/471 • Number of events 1
|
|
Nervous system disorders
Upper motor neurone lesion
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Addiction relapse
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Aggression
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/472
|
1.1%
5/471 • Number of events 5
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Psychiatric disorders
Altercation
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Anger
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Anxiety
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Attempted suicide
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Auditory and visual hallucinations
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Auditory hallucinations
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Psychiatric disorders
Confusion
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Delirium
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Depression
|
0.21%
1/472 • Number of events 1
|
1.5%
7/471 • Number of events 7
|
|
Psychiatric disorders
Depression worsened
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Psychiatric disorders
Dissociation
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Drug abuse
|
0.42%
2/472 • Number of events 3
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Drug-induced psychosis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Homicidal ideation
|
0.85%
4/472 • Number of events 6
|
1.3%
6/471 • Number of events 6
|
|
Psychiatric disorders
Hypomania
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Major depression
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Mental disorder
|
0.64%
3/472 • Number of events 3
|
1.7%
8/471 • Number of events 8
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/472
|
0.21%
1/471 • Number of events 2
|
|
Psychiatric disorders
Opioid abuse
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/472
|
0.21%
1/471 • Number of events 2
|
|
Psychiatric disorders
Polysubstance dependence
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Psychiatric disorder NOS
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Psychiatric disorders
Psychiatric symptom
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Psychosis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Psychotic episode
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Stress symptoms
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Substance abuse
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Suicidal depression
|
0.42%
2/472 • Number of events 2
|
1.1%
5/471 • Number of events 6
|
|
Psychiatric disorders
Suicidal ideation
|
6.1%
29/472 • Number of events 37
|
5.1%
24/471 • Number of events 37
|
|
Psychiatric disorders
Suicidal plans
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Suicide
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Suicide attempt
|
1.3%
6/472 • Number of events 9
|
0.42%
2/471 • Number of events 2
|
|
Psychiatric disorders
Suicide gesture
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Renal and urinary disorders
Kidney stones
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Renal and urinary disorders
Membranous nephropathy
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Renal and urinary disorders
Renal failure
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Renal and urinary disorders
Ureteral calculus
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hypertrophy
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Reproductive system and breast disorders
Enlarged prostate
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarian cyst NOS
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonitis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic attack
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Breath shortness
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
1.1%
5/472 • Number of events 11
|
1.1%
5/471 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
0.00%
0/472
|
0.21%
1/471 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty breathing
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.42%
2/472 • Number of events 2
|
0.21%
1/471 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hilar mass
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/472
|
0.85%
4/471 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Short of breath
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Throat lesion
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Skin and subcutaneous tissue disorders
Allergic angioedema
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.21%
1/472 • Number of events 1
|
0.42%
2/471 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechial rash
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Social circumstances
Alcohol use
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Social circumstances
Burglary victim
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Social circumstances
Physical assault
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Social circumstances
Treatment noncompliance
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Appendectomy
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Artificial urinary sphincter implant
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Atherectomy
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Back surgery
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Surgical and medical procedures
Bladder tumor resection
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Bowel resection
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Bypass surgery
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
C-section
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Cholecystectomy
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Surgical and medical procedures
Drug detoxification
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Drug rehabilitation
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Elective surgery
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Foot surgery
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Fusion cervical spine
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Fusion of vertebra
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Gallbladder operation
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Gastrostomy tube insertion
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Hernia repair
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Hernia repair NOS
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Hip replacement
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Knee operation
|
0.21%
1/472 • Number of events 1
|
0.42%
2/471 • Number of events 2
|
|
Surgical and medical procedures
Knee total replacement
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Lobectomy (thyroid)
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Lumbar laminectomy
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Lung operation
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Mass excision
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Penile operation
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Physical therapy
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Prostate transurethral resection
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Prostatectomy
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Surgical and medical procedures
Shoulder replacement
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Splenectomy
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Total abdominal hysterectomy
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Surgical and medical procedures
Total knee replacement
|
0.42%
2/472 • Number of events 2
|
0.64%
3/471 • Number of events 3
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Uvulectomy
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Vascular disorders
Aneurysm of abdominal aorta
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Vascular disorders
Arterial occlusive disease
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Vascular disorders
Blood pressure high
|
0.42%
2/472 • Number of events 2
|
0.42%
2/471 • Number of events 2
|
|
Vascular disorders
Deep vein thrombosis leg
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Vascular disorders
Hematoma
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Vascular disorders
Hypertension
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Vascular disorders
Hypotensive episode
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Vascular disorders
Iliac artery stenosis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Vascular disorders
Orthostatic hypotension
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Vascular disorders
Peripheral vascular disease
|
0.42%
2/472 • Number of events 2
|
0.42%
2/471 • Number of events 2
|
|
Vascular disorders
Peripheral vascular disease NOS
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Vascular disorders
Popliteal artery aneurysm
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Vascular disorders
Superficial femoral arterial stenosis
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Vascular disorders
Thrombosis arm
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Vascular disorders
Thrombosis leg
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
Other adverse events
| Measure |
Integrated Care
n=472 participants at risk
Integration of smoking cessation therapy with PTSD therapy.
|
Standard of Care
n=471 participants at risk
Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
|
|---|---|---|
|
General disorders
Unevaluable event
|
0.42%
2/472 • Number of events 2
|
0.42%
2/471 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Eye disorders
Blurry vision
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Gastrointestinal disorders
Dyspepsia
|
0.21%
1/472 • Number of events 2
|
0.21%
1/471 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Gastrointestinal disorders
Gas
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Gastrointestinal disorders
Gastric pain
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Gastrointestinal disorders
Upset stomach
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
General disorders
Chest pain
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
General disorders
Flu like symptoms
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
General disorders
Irritability
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Investigations
Weight gain
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Nervous system disorders
Tremor
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Abnormal dreams
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Abnormal thinking
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Aggression
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Agitated
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Anger
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Psychiatric disorders
Auditory hallucinations
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Bad dreams
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Behavior abnormal
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Bizarre dreams
|
0.21%
1/472 • Number of events 1
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Depression
|
0.00%
0/472
|
0.85%
4/471 • Number of events 4
|
|
Psychiatric disorders
Depression worsened
|
1.5%
7/472 • Number of events 7
|
0.64%
3/471 • Number of events 3
|
|
Psychiatric disorders
Difficulty sleeping
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Psychiatric disorders
Dreaming excessive
|
0.00%
0/472
|
0.42%
2/471 • Number of events 2
|
|
Psychiatric disorders
Emotional distress
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Frightening dreams
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Increased agitation
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Lack of motivation
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Mood change
|
0.42%
2/472 • Number of events 2
|
0.00%
0/471
|
|
Psychiatric disorders
Mood swings
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Nervousness
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Nightmares
|
0.42%
2/472 • Number of events 2
|
1.1%
5/471 • Number of events 5
|
|
Psychiatric disorders
Panic attack
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Panic attacks
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Paranoia aggravated
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Sleep disturbance
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideation
|
1.3%
6/472 • Number of events 7
|
1.7%
8/471 • Number of events 8
|
|
Psychiatric disorders
Suicide attempt
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Violent behavior
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Psychiatric disorders
Vivid dreams
|
0.21%
1/472 • Number of events 1
|
0.64%
3/471 • Number of events 4
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Skin and subcutaneous tissue disorders
Drug rash
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Skin and subcutaneous tissue disorders
Generalized itching
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.21%
1/472 • Number of events 1
|
0.00%
0/471
|
|
Vascular disorders
Blood pressure high
|
0.00%
0/472
|
0.21%
1/471 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place