Trial Outcomes & Findings for Patch Study - Intervention for HIV Positive Smokers (NCT NCT02982772)
NCT ID: NCT02982772
Last Updated: 2021-10-06
Results Overview
verified continuous abstinence (carbon monoxide \< 10ppm and cotinine \<15 ng/mL).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
488 participants
Primary outcome timeframe
3 months
Results posted on
2021-10-06
Participant Flow
Participants were recruited with flyers and by referrals.
488 participants signed consent forms, a total 11 were excluded (6 did not meet smoking criteria, 3 were not compliant, and 2 had pre-existing medical conditions).
Participant milestones
| Measure |
Tailored Combination Therapy
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
|---|---|---|
|
Enrollment
STARTED
|
245
|
243
|
|
Enrollment
COMPLETED
|
245
|
243
|
|
Enrollment
NOT COMPLETED
|
0
|
0
|
|
Intervention
STARTED
|
245
|
243
|
|
Intervention
COMPLETED
|
226
|
230
|
|
Intervention
NOT COMPLETED
|
19
|
13
|
|
1M Follow-Up
STARTED
|
226
|
230
|
|
1M Follow-Up
COMPLETED
|
205
|
212
|
|
1M Follow-Up
NOT COMPLETED
|
21
|
18
|
|
3M Follow-Up
STARTED
|
205
|
212
|
|
3M Follow-Up
COMPLETED
|
188
|
201
|
|
3M Follow-Up
NOT COMPLETED
|
17
|
11
|
|
6M Follow-Up
STARTED
|
188
|
201
|
|
6M Follow-Up
COMPLETED
|
177
|
192
|
|
6M Follow-Up
NOT COMPLETED
|
11
|
9
|
|
12M Follow-Up
STARTED
|
177
|
192
|
|
12M Follow-Up
COMPLETED
|
166
|
187
|
|
12M Follow-Up
NOT COMPLETED
|
11
|
5
|
Reasons for withdrawal
| Measure |
Tailored Combination Therapy
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
|---|---|---|
|
Intervention
Lost to Follow-up
|
19
|
13
|
|
1M Follow-Up
Lost to Follow-up
|
21
|
18
|
|
3M Follow-Up
Lost to Follow-up
|
17
|
11
|
|
6M Follow-Up
Lost to Follow-up
|
11
|
9
|
|
12M Follow-Up
Lost to Follow-up
|
11
|
5
|
Baseline Characteristics
Patch Study - Intervention for HIV Positive Smokers
Baseline characteristics by cohort
| Measure |
Tailored Combination Therapy
n=245 Participants
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
n=243 Participants
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
Total
n=488 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.1 years
n=5 Participants
|
51.1 years
n=7 Participants
|
51.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
33 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic White
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic Black
|
197 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
399 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
245 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
488 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: This is the total number of participants in each arm that quit smoking at 3 months.
verified continuous abstinence (carbon monoxide \< 10ppm and cotinine \<15 ng/mL).
Outcome measures
| Measure |
Tailored Combination Therapy
n=188 Participants
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
n=201 Participants
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
|---|---|---|
|
Rates of Smoking Cessation
|
57 Participants
|
46 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This is the total number of participants in each arm that quit smoking at 6 months. However due to the pandemic we could not verified with biomarkers
verified continuous abstinence (carbon monoxide \< 10ppm and cotinine \<15 ng/mL).
Outcome measures
| Measure |
Tailored Combination Therapy
n=177 Number of pts that quit
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
n=192 Number of pts that quit
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
|---|---|---|
|
Rates of Smoking Cessation
|
40 Number of pts that quit
|
28 Number of pts that quit
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: This is the total number of participants in each arm that quit smoking at 12 months.
verified continuous abstinence (carbon monoxide \< 10ppm and cotinine \<15 ng/mL).
Outcome measures
| Measure |
Tailored Combination Therapy
n=166 Number of pts that quit
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
n=187 Number of pts that quit
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
|---|---|---|
|
Rates of Smoking Cessation
|
32 Number of pts that quit
|
28 Number of pts that quit
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Quality of Life change at 6 months. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)
The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves: * CD4 (counts and percentage). * HIV Viral load (logs). * Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute). * Anthropometric measures \[Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches\]. * In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)
Outcome measures
| Measure |
Tailored Combination Therapy
n=177 Participants
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
n=192 Participants
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
|---|---|---|
|
Change in Clinical Outcomes
|
-1.9 score on a scale/change
Standard Deviation 8.8
|
0.38 score on a scale/change
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Verified abstinence at 3 months.
Verified continuous abstinence using a breathalyzer carbon monoxide \< 10ppm
Outcome measures
| Measure |
Tailored Combination Therapy
n=188 Participants
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
n=201 Participants
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
|---|---|---|
|
Number of Participants With Verified Continuous Abstinence
|
57 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Baseline-6 monthsPopulation: Total of number of participants in the Tailored \& Standard arms.
Total number of self reported side effects from Baseline through 6 months.
Outcome measures
| Measure |
Tailored Combination Therapy
n=245 Participants
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
n=243 Participants
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
|---|---|---|
|
Prevalence of Side Effects-safety
|
70 side effects
|
50 side effects
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Quality of Life change at 12 months. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome)
The investigators will analyze changes in the following parameters since baseline, and will be given one point for each parameter that improves: * CD4 (counts and percentage). * HIV Viral load (logs). * Vital signs (Blood pressure in mm Hg, breaths per minute, beats per minute). * Anthropometric measures \[Body Mass Index = weight(kilograms) / height(meters2), Waist and hip circumference in inches\]. Scale Title: Smoking Cessation Quality of Life (SCQoL) - Physical subscale Minimum 9, maximum 27 (higher scores=worse outcome) \- In health-related quality of life measured as changes in the total score of Health-Related Quality of Life survey.
Outcome measures
| Measure |
Tailored Combination Therapy
n=166 Participants
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
n=187 Participants
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
|---|---|---|
|
Change in Clinical Outcomes
|
0.85 score on a scale/change
Standard Deviation 5.9
|
0.82 score on a scale/change
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Verified abstinence at 6 months.
verified continuous abstinence using a breathalyzer carbon monoxide \< 10ppm
Outcome measures
| Measure |
Tailored Combination Therapy
n=177 Participants
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
n=192 Participants
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
|---|---|---|
|
Number of Participants With Verified Continuous Abstinence
|
49 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Verified abstinence at 12 months.
verified continuous abstinence using a breathalyzer carbon monoxide \< 10ppm
Outcome measures
| Measure |
Tailored Combination Therapy
n=166 Participants
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
n=187 Participants
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
|---|---|---|
|
Number of Participants With Verified Continuous Abstinence
|
32 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 6 through 12 monthsPopulation: Total of number of participants in the Tailored \& Standard arms.
Total number of self reported side effects from 6 through 12 months.
Outcome measures
| Measure |
Tailored Combination Therapy
n=245 Participants
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used. Doses will be tailored and adjusted as needed.
Combination Therapy: Brief Behavioral Intervention
The test product is a transdermal Nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
n=243 Participants
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is a transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
|---|---|---|
|
Prevalence of Side Effects-safety
|
31 side effects
|
33 side effects
|
Adverse Events
Tailored Combination Therapy
Serious events: 0 serious events
Other events: 101 other events
Deaths: 2 deaths
Standard Care Intervention
Serious events: 0 serious events
Other events: 83 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tailored Combination Therapy
n=245 participants at risk
Combination of Brief behavioral intervention Plus Nicotine replacement. The test product is a transdermal nicotine patch and Nicotine replacement gums for 12 weeks. The dosage of the test product depends on the amount of cigarettes used.
Doses will be tailored and adjust as need it
Combination Therapy: Brief behavioral intervention
The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks.
|
Standard Care Intervention
n=243 participants at risk
Brief behavioral intervention The test product is a transdermal nicotine patch plus regular flavored gums for 10 weeks. The dosage of the test product depends on the amount of cigarettes used.
Standard Flavored gums will be used as needed for 10 weeks.
Standard Care Intervention: Brief Behavioral Intervention
The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
Standard Flavored Gums for 10 weeks
|
|---|---|---|
|
General disorders
Jaw Pain
|
2.9%
7/245 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
2.5%
6/243 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
|
General disorders
Dry Mouth
|
25.3%
62/245 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
20.2%
49/243 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
5.3%
13/245 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
7.8%
19/243 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
|
Metabolism and nutrition disorders
Decrease Appetite
|
11.8%
29/245 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
9.1%
22/243 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
|
Nervous system disorders
Headache
|
14.7%
36/245 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
18.1%
44/243 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
|
Nervous system disorders
Dizziness
|
14.3%
35/245 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
13.6%
33/243 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
|
General disorders
Fatigue
|
15.5%
38/245 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
16.0%
39/243 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
|
General disorders
Sleepiness
|
15.5%
38/245 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
13.6%
33/243 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
|
Skin and subcutaneous tissue disorders
Itching
|
12.7%
31/245 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
16.5%
40/243 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
|
Psychiatric disorders
Vivid Dreams
|
0.41%
1/245 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
0.82%
2/243 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.41%
1/245 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
0.41%
1/243 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/245 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
0.41%
1/243 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
|
General disorders
Body Aches
|
0.00%
0/245 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
1.2%
3/243 • Adverse events were collected from Enrollment through the 12 month visit. At each study visit, participants completed a questionnaire regarding side effects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place