Trial Outcomes & Findings for Effect of Medical Marijuana on Neurocognition and Escalation of Use (NCT NCT03224468)
NCT ID: NCT03224468
Last Updated: 2023-11-15
Results Overview
The DSM-5 Cannabis Use Disorder (CUD) Checklist will evaluate symptoms of CUD (number of symptoms). The scale ranges from 0-11, with a higher score indicating a greater number of cannabis use disorder symptoms. A trained member of study staff assessed number of CUD symptoms through a structured interview. Each item was scored as "1" if the participant endorsed the symptom, and scored as "0" if they did not endorse the symptom. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
COMPLETED
NA
269 participants
2 weeks, 4 weeks, and 12 weeks
2023-11-15
Participant Flow
Participant milestones
| Measure |
Medical Marijuana Arm
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
Waitlist Control Arm
This group agrees to wait 3 months before using medical marijuana.
|
|---|---|---|
|
Overall Study
STARTED
|
173
|
96
|
|
Overall Study
COMPLETED
|
105
|
81
|
|
Overall Study
NOT COMPLETED
|
68
|
15
|
Reasons for withdrawal
| Measure |
Medical Marijuana Arm
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
Waitlist Control Arm
This group agrees to wait 3 months before using medical marijuana.
|
|---|---|---|
|
Overall Study
Did not obtain MM card
|
53
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
11
|
|
Overall Study
Cannabis Use Disorder at Baseline
|
11
|
4
|
Baseline Characteristics
Effect of Medical Marijuana on Neurocognition and Escalation of Use
Baseline characteristics by cohort
| Measure |
Medical Marijuana Arm
n=105 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
Waitlist Control Arm
n=81 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
37.2 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
101 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=5 Participants
|
81 participants
n=7 Participants
|
186 participants
n=5 Participants
|
|
Education Level
High School
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Education Level
Part College
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Education Level
College 2 Years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education Level
College 4 Years
|
35 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Education Level
Part Grad School
|
46 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Education Level
Unknown
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education Years
|
16.6 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
16.3 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
16.5 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Cannabis Use Frequency
Used less than weekly
|
82 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Cannabis Use Frequency
Used weekly or more
|
23 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Primary Complaint
Pain
|
37 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Primary Complaint
Insomnia
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Primary Complaint
Anxiety/Depression
|
46 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks, and 12 weeksThe DSM-5 Cannabis Use Disorder (CUD) Checklist will evaluate symptoms of CUD (number of symptoms). The scale ranges from 0-11, with a higher score indicating a greater number of cannabis use disorder symptoms. A trained member of study staff assessed number of CUD symptoms through a structured interview. Each item was scored as "1" if the participant endorsed the symptom, and scored as "0" if they did not endorse the symptom. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=81 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=105 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Number of Cannabis Use Disorder Symptoms Averaged Over 2, 4, and 12 Weeks
|
0.12 score on a scale
Standard Deviation 0.48
|
0.39 score on a scale
Standard Deviation 0.78
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks, and 12 weeksPopulation: The analysis is restricted to the subset of 83 participants out of 186 total who intended to use medical marijuana to address concerns for anxiety and depression.
For those with depression symptoms, the depression subscale of the Hospital Anxiety and Depression Scale (HADS) will be used to assess symptoms. The subscale ranges from 0-21, with a higher score indicating worse depression outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=37 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=46 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Depression Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks
|
5.0 score on a scale
Standard Deviation 3.9
|
5.4 score on a scale
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: 2 Weeks, 4 Weeks, and 12 WeeksPopulation: The analysis is restricted to the subset of 83 participants out of 186 total who intended to use medical marijuana to address concerns for anxiety and depression.
For those with anxiety symptoms, the anxiety subscale from the Hospital Anxiety and Depression Scale (HADS) will be used to assess symptoms. This subscale ranges from 0-21, with higher scores indicating worse anxiety outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=37 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=46 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Anxiety Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks
|
8.4 units on a scale
Standard Deviation 3.8
|
8.4 units on a scale
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks, and 12 weeksPopulation: The analysis is restricted to the subset of 61 participants out of 186 total who intended to use medical marijuana to address concerns for pain.
For those with pain, the Brief Pain Inventory (BPI) severity subscale was used to assess pain symptoms. This scale ranges from 0-10, with a higher score indicating greater pain severity. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=24 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=37 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Pain Severity Scores on the BPI Average Over 2, 4, and 12 Weeks
|
3.3 score on a scale
Standard Deviation 2.5
|
2.7 score on a scale
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks, and 12 weeksPopulation: The analysis is restricted to the subset of 42 participants out of 186 total who intended to use medical marijuana to address concerns for insomnia.
For those with insomnia, the Athens Insomnia Scale (AIS) will be used to assess insomnia symptoms. This scale ranges from 0-24, with higher scores indicating worse sleep outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=20 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=22 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Sleep Scores on the AIS Averaged Over 2, 4, and 12 Weeks
|
11.6 score on a scale
Standard Deviation 3.7
|
8.8 score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: 2 weeks, 4 weeks, and 12 weeksThe Short Form-12 Health Survey (SF-12) Physical Health Summary Scale was used to assess self-report of physical health. SF-12 scores are based on an Item Response Theory model, in which they are z-scores rescaled to have a mean of 50 (SD=10) in any typical population. There are no range limits to this measure. Higher scores indicate better physical health functioning. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=81 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=105 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Physical Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks
|
48.2 score on a scale
Standard Deviation 11.8
|
47.1 score on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: 2 weeks, 4 weeks, and 12 weeksThe Short Form 12 Health Survey (SF-12) Mental Health Summary Scale was used to assess self-report of mental health. SF-12 scores are based on an Item Response Theory model, in which they are z-scores rescaled to have a mean of 50 (SD=10) in any typical population. This measure has no range limits. Higher scores indicate better mental health functioning. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=81 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=105 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Mental Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks
|
41.5 score on a scale
Standard Deviation 12.3
|
44.9 score on a scale
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: 4 weeks and 12 weeksPopulation: The analysis is restricted to the subset of 162 participants out of 186 total who completed the AST module of the CANTAB at weeks 4 and 12.
Congruency cost was assessed wth the Attention Switching Task (AST), which assesses attention shifting and executive function via a simple task assessing the direction (pointing left or right) and position (on the left or right side) of an arrow, and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range of this measure is -1900 to 1900 ms. It is calculated as the difference in the median latency for incongruent trials (i.e., trials where the direction of the arrow differs from the side it appears) minus the median latency for congruent trials (i.e., trials where the direction of the arrow matches the side it appears). Positive values indicate faster responses to congruent trials. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=67 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=95 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Attention Switching Task: Congruency Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks
|
77 milliseconds (ms)
Standard Deviation 50
|
63 milliseconds (ms)
Standard Deviation 43
|
SECONDARY outcome
Timeframe: 4 weeks and 12 weeksPopulation: The analysis is restricted to the subset of 162 participants out of 186 total who completed the AST module of the CANTAB at weeks 4 and 12.
Switching cost was assessed with the Attention Switching Task (AST), which assesses attention shifting and executive function via a simple task assessing the direction (pointing left or right) and position (on the left or right side) of an arrow, and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is -1900 to 1900 ms. It is calculated as the difference in the median latency for blocks of switching trials (i.e., blocks of trials where the response rule switches between indicating the direction of the arrow or the position of the arrow) minus the median latency for blocks of non-switching trials (i.e., blocks of trials where the response rule is always either to indicate the direction of the arrow or the position of the arrow across all trials). Positive scores indicate faster responses to non-switching trials. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=67 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=95 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Attention Switching Task: Switching Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks
|
162 milliseconds (ms)
Standard Deviation 107
|
139 milliseconds (ms)
Standard Deviation 90
|
SECONDARY outcome
Timeframe: 4 weeks and 12 weeksPopulation: The analysis is restricted to the subset of 177 participants out of 186 total who completed the RVP module of the CANTAB at weeks 4 and 12.
Discriminability was assessed with the Rapid Visual Information Processing (RVP) Task, which assesses sustained attention and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). Discriminability scores are based on a transformation of response times and accuracy using the EZ-Diffusion model. There are no limits for this measure. Higher scores indicate that subjects can better discriminator between targets and distractors. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=76 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=101 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Rapid Visual Information Processing (RVP) Task: Discriminability Scores on the CANTAB Averaged Over 4 and 12 Weeks
|
0.058 score on a scale
Standard Deviation 0.044
|
0.076 score on a scale
Standard Deviation 0.047
|
SECONDARY outcome
Timeframe: 4 weeks and 12 weeksPopulation: The analysis is restricted to the subset of 177 participants out of 186 total who completed the PAL module of the CANTAB at weeks 4 and 12.
Total errors were assessed with the Paired Associates Learning (PAL) task, which assesses visual memory and is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is 0 to 70 errors. Higher scores indicate that the subject committed more errors (worse performance). Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=76 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=101 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Paired Associates Learning (PAL) Task: Total Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks
|
9.3 Number of errors
Standard Deviation 11.6
|
9.1 Number of errors
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 4 weeks and 12 weeksPopulation: The analysis is restricted to the subset of 177 participants out of 186 total who completed the ? module of the CANTAB at weeks 4 and 12.
Repetition errors were assessed with the Spatial Working Memory (SWM) task, which assesses spatial working memory and executive function. It is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is 0 to 63 errors. Higher scores indicate that more repetition errors were committed (worse performance). Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=76 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=101 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Spatial Working Memory (SWM) Task: Repetition Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks
|
30.0 Number of errors
Standard Deviation 19.8
|
26.4 Number of errors
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: 4 weeks and 12 weeksPopulation: The analysis is restricted to the subset of 171 participants out of 186 total who completed the VRM module of the CANTAB at weeks 4 and 12.
Discriminability was assessed with the Verbal Recognition Memory task (VRM), which assess verbal memory. It is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). Discriminability scores are based on a transformation of hit and false alarm rates using a signal detection theory (SDT) model.There are no limits for this measure. Higher scores indicate that a subject was able to better discriminate between previously studied and novel words. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=73 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=98 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Verbal Recognition Memory (VRM) Task: d' Scores on the CANTAB Averaged Over 4 and 12 Weeks
|
2.7 score on a scale
Standard Deviation 0.7
|
2.6 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 4 weeks and 12 weeksPopulation: The analysis is restricted to the subset of 175 participants out of 186 total who completed the free recall VRM module of the CANTAB at weeks 4 and 12.
Free Recall Memory was assessed with the Verbal Recognition Memory task (VRM), which assesses verbal memory. It is part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). The range for this measure is 0 to 18 words recalled. Higher scores indicate that subjects were able to correctly recall more previously studied words. Reported results are an average taken over weeks 4 and 12 to be consistent with the regression model estimates.
Outcome measures
| Measure |
Waitlist Control Arm
n=74 Participants
This group agrees to wait 3 months before using medical marijuana.
|
Medical Marijuana Arm
n=101 Participants
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
|---|---|---|
|
Mean Difference in Verbal Recognition Memory (VRM) Task: Free Recall Memory Scores on the CANTAB Averaged Over 4 and 12 Weeks
|
8.5 Total recalled
Standard Deviation 2.8
|
8.9 Total recalled
Standard Deviation 2.7
|
Adverse Events
Medical Marijuana Arm
Waitlist Control Arm
Serious adverse events
| Measure |
Medical Marijuana Arm
n=105 participants at risk
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
Waitlist Control Arm
n=81 participants at risk
This group agrees to wait 3 months before using medical marijuana.
|
|---|---|---|
|
Cardiac disorders
Cardiac Ablation
|
0.95%
1/105 • Number of events 1 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
0.00%
0/81 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
Other adverse events
| Measure |
Medical Marijuana Arm
n=105 participants at risk
This group can begin using medical marijuana immediately.
Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use.
|
Waitlist Control Arm
n=81 participants at risk
This group agrees to wait 3 months before using medical marijuana.
|
|---|---|---|
|
Infections and infestations
Infections and infestations
|
47.6%
50/105 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
38.3%
31/81 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
|
Psychiatric disorders
Psychiatric symptoms
|
29.5%
31/105 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
25.9%
21/81 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
|
General disorders
General disorders and conditions
|
30.5%
32/105 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
16.0%
13/81 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
|
Nervous system disorders
Nervous system symptoms
|
12.4%
13/105 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
9.9%
8/81 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
|
Injury, poisoning and procedural complications
Injury and poisoning
|
11.4%
12/105 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
12.3%
10/81 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
13.3%
14/105 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
6.2%
5/81 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders
|
6.7%
7/105 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
4.9%
4/81 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorders
|
1.9%
2/105 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
9.9%
8/81 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
|
Immune system disorders
Immune system disorders
|
3.8%
4/105 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
6.2%
5/81 • Adverse event data was collected for 3 months.
Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place