Trial Outcomes & Findings for Preventing Weight Gain and Controlling Blood Pressure During Smoking Cessation in Hypertensive Smokers (NCT NCT00113074)
NCT ID: NCT00113074
Last Updated: 2024-04-29
Results Overview
Change in systolic blood pressure in mmHg
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
139 participants
Primary outcome timeframe
Measured at Year 1
Results posted on
2024-04-29
Participant Flow
Participant milestones
| Measure |
1 - Weight Management and Blood Pressure Control Intervention
Weight management and blood pressure control intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
3 - Self-help Materials Targeting Lifestyle Modification
Self-help materials targeting lifestyle modification
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
2 - Weight Management Intervention
Weight management intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
43
|
47
|
|
Overall Study
COMPLETED
|
39
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
14
|
Reasons for withdrawal
| Measure |
1 - Weight Management and Blood Pressure Control Intervention
Weight management and blood pressure control intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
3 - Self-help Materials Targeting Lifestyle Modification
Self-help materials targeting lifestyle modification
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
2 - Weight Management Intervention
Weight management intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
10
|
14
|
Baseline Characteristics
Data missing for 5 participants.
Baseline characteristics by cohort
| Measure |
1 - Weight Management and Blood Pressure Control Intervention
n=49 Participants
Weight management and blood pressure control intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
3 - Self-help Materials Targeting Lifestyle Modification
n=43 Participants
Self-help materials targeting lifestyle modification
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
2 - Weight Management Intervention
n=47 Participants
Weight management intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Diastolic Blood Pressure
|
79.3 mmHg
STANDARD_DEVIATION 8.4 • n=48 Participants • Data missing for 5 participants.
|
79.1 mmHg
STANDARD_DEVIATION 8.7 • n=42 Participants • Data missing for 5 participants.
|
77.9 mmHg
STANDARD_DEVIATION 9.5 • n=43 Participants • Data missing for 5 participants.
|
78.8 mmHg
STANDARD_DEVIATION 8.8 • n=133 Participants • Data missing for 5 participants.
|
|
Body Mass Index
|
30.6 kg/m^2
STANDARD_DEVIATION 7.6 • n=48 Participants • Data missing for three participants
|
29.5 kg/m^2
STANDARD_DEVIATION 6.2 • n=43 Participants • Data missing for three participants
|
30.0 kg/m^2
STANDARD_DEVIATION 6.1 • n=44 Participants • Data missing for three participants
|
30.1 kg/m^2
STANDARD_DEVIATION 6.6 • n=135 Participants • Data missing for three participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=49 Participants • One participant had missing data on this variable.
|
0 Participants
n=43 Participants • One participant had missing data on this variable.
|
0 Participants
n=46 Participants • One participant had missing data on this variable.
|
0 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=49 Participants • One participant had missing data on this variable.
|
38 Participants
n=43 Participants • One participant had missing data on this variable.
|
41 Participants
n=46 Participants • One participant had missing data on this variable.
|
124 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Age, Categorical
>=65 years
|
4 Participants
n=49 Participants • One participant had missing data on this variable.
|
5 Participants
n=43 Participants • One participant had missing data on this variable.
|
5 Participants
n=46 Participants • One participant had missing data on this variable.
|
14 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 13.8 • n=49 Participants
|
46.6 years
STANDARD_DEVIATION 13.1 • n=43 Participants
|
47.3 years
STANDARD_DEVIATION 14.2 • n=47 Participants
|
46.6 years
STANDARD_DEVIATION 13.6 • n=139 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=49 Participants • One participant had missing data on this variable.
|
13 Participants
n=43 Participants • One participant had missing data on this variable.
|
18 Participants
n=46 Participants • One participant had missing data on this variable.
|
50 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Sex: Female, Male
Male
|
30 Participants
n=49 Participants • One participant had missing data on this variable.
|
30 Participants
n=43 Participants • One participant had missing data on this variable.
|
28 Participants
n=46 Participants • One participant had missing data on this variable.
|
88 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=49 Participants • One participant had missing data on this variable.
|
2 Participants
n=43 Participants • One participant had missing data on this variable.
|
0 Participants
n=46 Participants • One participant had missing data on this variable.
|
4 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=49 Participants • One participant had missing data on this variable.
|
41 Participants
n=43 Participants • One participant had missing data on this variable.
|
46 Participants
n=46 Participants • One participant had missing data on this variable.
|
134 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=49 Participants • One participant had missing data on this variable.
|
0 Participants
n=43 Participants • One participant had missing data on this variable.
|
0 Participants
n=46 Participants • One participant had missing data on this variable.
|
0 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=49 Participants • One participant had missing data on this variable.
|
0 Participants
n=43 Participants • One participant had missing data on this variable.
|
1 Participants
n=46 Participants • One participant had missing data on this variable.
|
2 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=49 Participants • One participant had missing data on this variable.
|
0 Participants
n=43 Participants • One participant had missing data on this variable.
|
0 Participants
n=46 Participants • One participant had missing data on this variable.
|
0 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=49 Participants • One participant had missing data on this variable.
|
0 Participants
n=43 Participants • One participant had missing data on this variable.
|
0 Participants
n=46 Participants • One participant had missing data on this variable.
|
0 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=49 Participants • One participant had missing data on this variable.
|
3 Participants
n=43 Participants • One participant had missing data on this variable.
|
0 Participants
n=46 Participants • One participant had missing data on this variable.
|
6 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Race (NIH/OMB)
White
|
44 Participants
n=49 Participants • One participant had missing data on this variable.
|
39 Participants
n=43 Participants • One participant had missing data on this variable.
|
45 Participants
n=46 Participants • One participant had missing data on this variable.
|
128 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=49 Participants • One participant had missing data on this variable.
|
1 Participants
n=43 Participants • One participant had missing data on this variable.
|
0 Participants
n=46 Participants • One participant had missing data on this variable.
|
2 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=49 Participants • One participant had missing data on this variable.
|
0 Participants
n=43 Participants • One participant had missing data on this variable.
|
0 Participants
n=46 Participants • One participant had missing data on this variable.
|
0 Participants
n=138 Participants • One participant had missing data on this variable.
|
|
Region of Enrollment
United States
|
49 participants
n=49 Participants
|
43 participants
n=43 Participants
|
47 participants
n=47 Participants
|
139 participants
n=139 Participants
|
|
Systolic Blood Pressure
|
130.3 mmHg
STANDARD_DEVIATION 11.3 • n=48 Participants • Data missing for 5 participants
|
131.6 mmHg
STANDARD_DEVIATION 11.5 • n=42 Participants • Data missing for 5 participants
|
128.8 mmHg
STANDARD_DEVIATION 12.2 • n=43 Participants • Data missing for 5 participants
|
130.2 mmHg
STANDARD_DEVIATION 11.6 • n=133 Participants • Data missing for 5 participants
|
PRIMARY outcome
Timeframe: Measured at Year 1Population: Participants still abstinent from smoking at one year who attended 12-month follow-up.
Change in systolic blood pressure in mmHg
Outcome measures
| Measure |
2 - Weight Management Intervention
n=14 Participants
Weight management intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program focused on energy restriction
|
Weight Management and Blood Pressure Control Intervention
n=23 Participants
Weight management and blood pressure control intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
Self-help Materials Targeting Lifestyle Modification
n=12 Participants
Self-help materials targeting lifestyle modification
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
|---|---|---|---|
|
Change in Systolic Blood Pressure at One Year Among People Who Have Quit Smoking
|
-1.64 millimeters of mercury (mmHg)
Standard Deviation 10.62
|
-1.78 millimeters of mercury (mmHg)
Standard Deviation 12.81
|
-0.17 millimeters of mercury (mmHg)
Standard Deviation 11.42
|
PRIMARY outcome
Timeframe: Measured at Year 1Population: Participants still abstinent from smoking at one year who attended 12-month follow-up.
Change in diastolic blood pressure in mmHg
Outcome measures
| Measure |
2 - Weight Management Intervention
n=14 Participants
Weight management intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program focused on energy restriction
|
Weight Management and Blood Pressure Control Intervention
n=23 Participants
Weight management and blood pressure control intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
Self-help Materials Targeting Lifestyle Modification
n=12 Participants
Self-help materials targeting lifestyle modification
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure at One Year Among People Who Have Quit Smoking
|
0.93 millimeters of mercury (mmHg)
Standard Deviation 7.38
|
-0.35 millimeters of mercury (mmHg)
Standard Deviation 8.62
|
-1.17 millimeters of mercury (mmHg)
Standard Deviation 5.77
|
SECONDARY outcome
Timeframe: Measured at Year 1Population: Randomized participants who were still abstinent from smoking at 12 months and who provided weight data.
Change in body weight in pounds from randomization to 12 months.
Outcome measures
| Measure |
2 - Weight Management Intervention
n=15 Participants
Weight management intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program focused on energy restriction
|
Weight Management and Blood Pressure Control Intervention
n=24 Participants
Weight management and blood pressure control intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
Self-help Materials Targeting Lifestyle Modification
n=12 Participants
Self-help materials targeting lifestyle modification
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
|---|---|---|---|
|
Changes in Body Weight
|
6.20 Pounds
Standard Deviation 7.99
|
3.07 Pounds
Standard Deviation 10.40
|
2.73 Pounds
Standard Deviation 9.17
|
SECONDARY outcome
Timeframe: Measured at Year 1Population: Randomized participants who were still abstinent from tobacco use at 12 months and who provided follow-up data.
Change in self-reported daily fruit and vegetable consumption from randomization to 12 months. Fruit and vegetable consumption was measured by self-report using a dietary screener, which provides results in the form of number of servings per day.
Outcome measures
| Measure |
2 - Weight Management Intervention
n=15 Participants
Weight management intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program focused on energy restriction
|
Weight Management and Blood Pressure Control Intervention
n=23 Participants
Weight management and blood pressure control intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
Self-help Materials Targeting Lifestyle Modification
n=12 Participants
Self-help materials targeting lifestyle modification
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
|---|---|---|---|
|
Dietary Intake - Fruit and Vegetable Consumption
|
-0.29 Servings of fruits and vegetables/day
Standard Deviation 3.31
|
1.32 Servings of fruits and vegetables/day
Standard Deviation 3.31
|
-3.46 Servings of fruits and vegetables/day
Standard Deviation 6.49
|
SECONDARY outcome
Timeframe: Measured at Year 1Population: Participants from Rochester site who were abstinent from smoking at one-year and who provided urinary chloride data at randomization visit and one-year. Urinary chloride data are not available from the Iowa City site.
Percent change in urinary sodium chloride (NaCL) from randomization to one-year
Outcome measures
| Measure |
2 - Weight Management Intervention
n=7 Participants
Weight management intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program focused on energy restriction
|
Weight Management and Blood Pressure Control Intervention
n=3 Participants
Weight management and blood pressure control intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
Self-help Materials Targeting Lifestyle Modification
n=6 Participants
Self-help materials targeting lifestyle modification
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
|---|---|---|---|
|
Urinary Sodium Chloride Excretion
|
-.05 Percent change in urinary NaCL excretion
Standard Deviation .07
|
.01 Percent change in urinary NaCL excretion
Standard Deviation .10
|
.05 Percent change in urinary NaCL excretion
Standard Deviation .18
|
SECONDARY outcome
Timeframe: Measured at Year 1Population: Participants who remained abstinent from tobacco use and who provided physical activity data at randomization and one-year.
Change in leisure time physical activity in metabolic equivalents (METs) from randomization to one-year. METs reflect the ratio of working metabolic rate relative to resting metabolic rate, and are expressed as the energy expended per unit of time. For this study, METs were measured based on self-reported physical activity using the International Physical Activity Questionnaire (IPAQ) and are reported in the form of MET minutes.
Outcome measures
| Measure |
2 - Weight Management Intervention
n=14 Participants
Weight management intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program focused on energy restriction
|
Weight Management and Blood Pressure Control Intervention
n=21 Participants
Weight management and blood pressure control intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
Self-help Materials Targeting Lifestyle Modification
n=10 Participants
Self-help materials targeting lifestyle modification
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
|---|---|---|---|
|
Physical Activity: Leisure Time Physical Activity in METs
|
-1383.5 MET minutes
Standard Deviation 2557.6
|
293.7 MET minutes
Standard Deviation 1000.4
|
277.5 MET minutes
Standard Deviation 1862.4
|
SECONDARY outcome
Timeframe: Measured at Year 1Population: Participants randomized to treatment groups.
Number of participants who self-reported tobacco use during the last seven-days.
Outcome measures
| Measure |
2 - Weight Management Intervention
n=46 Participants
Weight management intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program focused on energy restriction
|
Weight Management and Blood Pressure Control Intervention
n=49 Participants
Weight management and blood pressure control intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
Self-help Materials Targeting Lifestyle Modification
n=43 Participants
Self-help materials targeting lifestyle modification
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
|---|---|---|---|
|
Relapse to Smoking
|
30 Participants
|
24 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Measured at Year 1Population: Randomized participants who were still abstinent from tobacco use at 12 months and who provided follow-up data.
Change in daily dietary fat consumption from randomization to 12 months.
Outcome measures
| Measure |
2 - Weight Management Intervention
n=14 Participants
Weight management intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program focused on energy restriction
|
Weight Management and Blood Pressure Control Intervention
n=21 Participants
Weight management and blood pressure control intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
Self-help Materials Targeting Lifestyle Modification
n=12 Participants
Self-help materials targeting lifestyle modification
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
|---|---|---|---|
|
Dietary Intake - Dietary Fat Consumption
|
-0.88 Grams of dietary fat consumed/d
Standard Deviation 2.79
|
-2.39 Grams of dietary fat consumed/d
Standard Deviation 4.71
|
-0.81 Grams of dietary fat consumed/d
Standard Deviation 2.99
|
Adverse Events
Weight Management and Blood Pressure Control Intervention
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Self-help Materials Targeting Lifestyle Modification
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Weight Management Intervention
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Weight Management and Blood Pressure Control Intervention
n=49 participants at risk
Weight management and blood pressure control intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
Self-help Materials Targeting Lifestyle Modification
n=43 participants at risk
Self-help materials targeting lifestyle modification
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
Weight Management Intervention
n=47 participants at risk
Weight management intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney Cancer
|
0.00%
0/49 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
2.3%
1/43 • Number of events 1 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
0.00%
0/47 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/49 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
0.00%
0/43 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
2.1%
1/47 • Number of events 1 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
Other adverse events
| Measure |
Weight Management and Blood Pressure Control Intervention
n=49 participants at risk
Weight management and blood pressure control intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
Self-help Materials Targeting Lifestyle Modification
n=43 participants at risk
Self-help materials targeting lifestyle modification
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
Weight Management Intervention
n=47 participants at risk
Weight management intervention
Nicotine Replacement Therapy: Nicotine replacement therapy program
Diet: Diet program
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Itching/irritation/rash/pain at nicotine patch site
|
8.2%
4/49 • Number of events 4 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
14.0%
6/43 • Number of events 6 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
12.8%
6/47 • Number of events 6 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
|
Musculoskeletal and connective tissue disorders
Other musculoskeletal pain/injury
|
8.2%
4/49 • Number of events 4 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
2.3%
1/43 • Number of events 1 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
6.4%
3/47 • Number of events 3 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
|
Nervous system disorders
Nightmares/strange or vivid dreams
|
4.1%
2/49 • Number of events 2 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
4.7%
2/43 • Number of events 2 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
8.5%
4/47 • Number of events 4 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection/cold
|
28.6%
14/49 • Number of events 14 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
23.3%
10/43 • Number of events 10 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
23.4%
11/47 • Number of events 11 • 1 year
Coded for intensity (Mild, Moderate, Severe, Unknown), Seriousness (Not serious, Serious/not life threatening, Life threatening, Fatal), Relationship to study (Not related, Remote, Possible, Probable, Definite), Action (None, Concomitant medication required, Study drug discontinued temporarily, Study drug discontinued permanently, MD visit, Hospitalization, Other, Unknown), Outcome (Resolved, Continues resolving, Continuing but stable, Worsening, Other, Unknown), dates, and duration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place