Trial Outcomes & Findings for Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT00253747)
NCT ID: NCT00253747
Last Updated: 2012-09-17
Results Overview
The smoking quit date was considered the first day of the O-MPH/P-Stnd Smoking Tx phase, which lasted for 6 weeks or more precisely 42 days (i.e., approximately weeks 5-10). The grace period was the first two weeks (i.e., days 1-14) with the remaining four weeks (days 15-42) comprising the period in which the participant must not meet criteria for treatment failure in order to be scored as obtaining prolonged abstinence. Self-report of cigarette use was assessed using a time-line follow-back (TLFB) assessment using carbon monoxide (CO)levels to correct self-reported smoking days. "Smoking days" were determined by starting with self-reported smoking and non-smoking days and using CO levels measured at weekly visits to modify the self-reports.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
255 participants
Primary outcome timeframe
Weeks 7-10
Results posted on
2012-09-17
Participant Flow
This trial was conducted by the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) between December 2005 and January 2008. Six study sites recruited participants: 2 substance abuse community treatment programs, 2 Attention Deficit Hyperactivity Disorder (ADHD) clinics and 2 smoking cessation clinics.
Participant milestones
| Measure |
Osmotic-Release Methylphenidate (OROS-MPH)
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
128
|
|
Overall Study
COMPLETED
|
103
|
101
|
|
Overall Study
NOT COMPLETED
|
24
|
27
|
Reasons for withdrawal
| Measure |
Osmotic-Release Methylphenidate (OROS-MPH)
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
14
|
|
Overall Study
Withdrawal by Subject
|
10
|
11
|
|
Overall Study
Administrative Discharge (1), Other (2)
|
1
|
2
|
Baseline Characteristics
Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Osmotic-Release Methylphenidate (OROS-MPH)
n=127 Participants
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo
n=128 Participants
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
127 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
38.1 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
37.5 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
37.8 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
127 participants
n=5 Participants
|
128 participants
n=7 Participants
|
255 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 7-10Population: Randomized participants who complete at least two visits during the first four weeks following randomization, who reach the full dose of OROS-MPH /Placebo, who have a OROS-MPH /placebo medication compliance rate of at least 75% each week for study weeks 4 through 10, and who attend at least one meeting after initiating the nicotine patch.
The smoking quit date was considered the first day of the O-MPH/P-Stnd Smoking Tx phase, which lasted for 6 weeks or more precisely 42 days (i.e., approximately weeks 5-10). The grace period was the first two weeks (i.e., days 1-14) with the remaining four weeks (days 15-42) comprising the period in which the participant must not meet criteria for treatment failure in order to be scored as obtaining prolonged abstinence. Self-report of cigarette use was assessed using a time-line follow-back (TLFB) assessment using carbon monoxide (CO)levels to correct self-reported smoking days. "Smoking days" were determined by starting with self-reported smoking and non-smoking days and using CO levels measured at weekly visits to modify the self-reports.
Outcome measures
| Measure |
Osmotic-Release Methylphenidate (OROS-MPH)
n=38 Participants
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo
n=42 Participants
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH)-Week 11
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 11
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Release Methylphenidate (OROS-MPH)-Week 4
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 4
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Release Methylphenidate (OROS-MPH)-Week 7
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 7
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Release Methylphenidate (OROS-MPH)-Week 9
OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Methylphenidate (OROS-MPH) - Placebo-Week 9
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Prolonged Abstinence
|
25 participants
|
28 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Study weeks 1,4,7,9,11Population: Evaluable participants determined using criteria for same in the primary outcome.
A Generalized Estimating Equations(GEE)model which included treatment group, week, site, and treatment by week and site by week interaction effects was used to compare the groups on the DSM-IV ADHD total severity score (18 domains score at severity levels of 0\[none\]-3\[severe\]; maximum score 54) as measured at screening/baseline and study weeks 1-4 using the the interviewer-administered DSM-IV checklist and by the severity portion of the National Institute of Mental Health Clinical Global Impression (CGI) scale to rate the severity of the participant's ADHD symptoms. A single severity score ranging from 1 to 7 is yielded by the CGI severity scale.
Outcome measures
| Measure |
Osmotic-Release Methylphenidate (OROS-MPH)
n=38 Participants
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo
n=42 Participants
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH)-Week 11
n=38 Participants
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 11
n=42 Participants
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Release Methylphenidate (OROS-MPH)-Week 4
n=37 Participants
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 4
n=42 Participants
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Release Methylphenidate (OROS-MPH)-Week 7
n=35 Participants
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 7
n=42 Participants
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Release Methylphenidate (OROS-MPH)-Week 9
n=36 Participants
OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Methylphenidate (OROS-MPH) - Placebo-Week 9
n=40 Participants
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Diagnostic and Statistical Manual-IV(DSM-IV) ADHD Rating Scale
|
38.4 DSM IV ADHD Score
Standard Deviation 7.6
|
36.6 DSM IV ADHD Score
Standard Deviation 7.7
|
16.4 DSM IV ADHD Score
Standard Deviation 12.2
|
24.2 DSM IV ADHD Score
Standard Deviation 23.0
|
20.4 DSM IV ADHD Score
Standard Deviation 12.6
|
27.2 DSM IV ADHD Score
Standard Deviation 12.0
|
20 DSM IV ADHD Score
Standard Deviation 12.6
|
24 DSM IV ADHD Score
Standard Deviation 13.3
|
17.3 DSM IV ADHD Score
Standard Deviation 12.6
|
23.9 DSM IV ADHD Score
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: Week 11Population: Evaluable population determined as for primary outcome.
A logistic regression including site and treatment group will be used to model rates of achieving point prevalence abstinence as assessed at the final visit of the O-MPH/P-Stnd Smoking Tx phase. Point prevalence abstinence was defined as not smoking in the previous seven days based on self-report using the TLFB method and confirmed with a Carbon Monoxide (CO) level \<8 ppm.
Outcome measures
| Measure |
Osmotic-Release Methylphenidate (OROS-MPH)
n=38 Participants
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo
n=42 Participants
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH)-Week 11
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 11
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Release Methylphenidate (OROS-MPH)-Week 4
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 4
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Release Methylphenidate (OROS-MPH)-Week 7
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 7
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Release Methylphenidate (OROS-MPH)-Week 9
OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Methylphenidate (OROS-MPH) - Placebo-Week 9
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Point-prevalence Abstinence
|
24 participants
|
26 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Osmotic-Release Methylphenidate (OROS-MPH)
Serious events: 2 serious events
Other events: 35 other events
Deaths: 0 deaths
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Osmotic-Release Methylphenidate (OROS-MPH)
n=127 participants at risk
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo
n=128 participants at risk
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.79%
1/127 • Number of events 1
|
0.00%
0/128
|
|
Psychiatric disorders
Depression
|
0.79%
1/127 • Number of events 1
|
0.00%
0/128
|
Other adverse events
| Measure |
Osmotic-Release Methylphenidate (OROS-MPH)
n=127 participants at risk
For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
Osmotic-Release Methylphenidate (OROS-MPH) - Placebo
n=128 participants at risk
OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
|
|---|---|---|
|
Nervous system disorders
Headache
|
27.6%
35/127 • Number of events 35
|
21.9%
28/128 • Number of events 28
|
|
Psychiatric disorders
Nervousness
|
22.0%
28/127 • Number of events 28
|
16.4%
21/128 • Number of events 21
|
|
Psychiatric disorders
Anxiety
|
18.9%
24/127 • Number of events 24
|
14.1%
18/128 • Number of events 18
|
|
Psychiatric disorders
Insomnia
|
17.3%
22/127 • Number of events 22
|
13.3%
17/128 • Number of events 17
|
|
Infections and infestations
Nasopharyngitis
|
15.7%
20/127 • Number of events 20
|
10.9%
14/128 • Number of events 14
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
18.1%
23/127 • Number of events 23
|
5.5%
7/128 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
14.2%
18/127 • Number of events 18
|
7.8%
10/128 • Number of events 10
|
|
Gastrointestinal disorders
Dry Mouth
|
11.8%
15/127 • Number of events 15
|
5.5%
7/128 • Number of events 7
|
|
Psychiatric disorders
Abnormal Dreams
|
7.1%
9/127 • Number of events 9
|
7.0%
9/128 • Number of events 9
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.5%
7/127 • Number of events 7
|
7.8%
10/128 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
11/127 • Number of events 11
|
4.7%
6/128 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
10/127 • Number of events 10
|
3.1%
4/128 • Number of events 4
|
|
Psychiatric disorders
Initial Insomnia
|
7.1%
9/127 • Number of events 9
|
3.9%
5/128 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.5%
7/127 • Number of events 7
|
4.7%
6/128 • Number of events 6
|
|
Nervous system disorders
Dizziness
|
6.3%
8/127 • Number of events 8
|
3.9%
5/128 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
3.9%
5/127 • Number of events 5
|
5.5%
7/128 • Number of events 7
|
|
Gastrointestinal disorders
Toothache
|
3.9%
5/127 • Number of events 5
|
4.7%
6/128 • Number of events 6
|
|
Psychiatric disorders
Stress
|
3.9%
5/127 • Number of events 5
|
4.7%
6/128 • Number of events 6
|
|
Psychiatric disorders
Agitation
|
3.9%
5/127 • Number of events 5
|
3.9%
5/128 • Number of events 5
|
|
Psychiatric disorders
Sleep Disorder
|
3.9%
5/127 • Number of events 5
|
3.9%
5/128 • Number of events 5
|
|
Nervous system disorders
Psychomotor Hyperactivity
|
7.1%
9/127 • Number of events 9
|
0.78%
1/128 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
9/127 • Number of events 9
|
0.78%
1/128 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.1%
4/127 • Number of events 4
|
4.7%
6/128 • Number of events 6
|
|
Investigations
Heart Rate Increased
|
7.1%
9/127 • Number of events 9
|
0.78%
1/128 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
7.1%
9/127 • Number of events 9
|
0.78%
1/128 • Number of events 1
|
|
Psychiatric disorders
Depressed Mood
|
2.4%
3/127 • Number of events 3
|
4.7%
6/128 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Application Site Pruritus
|
3.9%
5/127 • Number of events 5
|
3.1%
4/128 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.5%
7/127 • Number of events 7
|
1.6%
2/128 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.4%
3/127 • Number of events 3
|
4.7%
6/128 • Number of events 6
|
|
General disorders
Dysgeusia
|
3.1%
4/127 • Number of events 4
|
3.1%
4/128 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
4.7%
6/127 • Number of events 6
|
1.6%
2/128 • Number of events 2
|
|
General disorders
Arthalagia
|
3.1%
4/127 • Number of events 4
|
3.1%
4/128 • Number of events 4
|
|
General disorders
Fatigue
|
11.8%
15/127 • Number of events 15
|
9.4%
12/128 • Number of events 12
|
|
Psychiatric disorders
Depression
|
5.5%
7/127 • Number of events 7
|
1.6%
2/128 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place