Trial Outcomes & Findings for Efficacy of rTMS in Bipolar Depression (NCT NCT02749006)
NCT ID: NCT02749006
Last Updated: 2025-02-10
Results Overview
The primary outcome was the change in score on the Montgomery-Asberg Depression Rating Scale from baseline to study end. A higher score means a worse outcome. Min value is 0, Max value is 60
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
Baseline, Week 2, Week 4
Results posted on
2025-02-10
Participant Flow
Participants were recruited by referral, as well as online and community advertisements 2 Canadian centers (University of British Columbia \[UBC\], British Columbia, Canada; and University of Calgary \[UC\], Alberta, Canada) between October 2016 and March 2020 .
Of the 71 assessed for eligibility 37 were randomized.
Participant milestones
| Measure |
Active iTBS rTMS
The active arm involves magnetic stimulation of the brain to the left dorsolateral prefrontal cortex (DLPFC) daily for four weeks. The active arm will be receiving intermittent Theta-Burst (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to deliver magnetic pulses.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression.
|
Sham rTMS
sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
Sham rTMS: Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of rTMS in Bipolar Depression
Baseline characteristics by cohort
| Measure |
Active iTBS rTMS
n=18 Participants
The active arm involves magnetic stimulation of the brain to the left dorsolateral prefrontal cortex (DLPFC) daily for four weeks. The active arm will be receiving intermittent Theta-Burst (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to deliver magnetic pulses.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression.
|
Sham rTMS
n=19 Participants
sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
Sham rTMS: Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.78 years
STANDARD_DEVIATION 13.71 • n=5 Participants
|
43.00 years
STANDARD_DEVIATION 14.34 • n=7 Participants
|
43.86 years
STANDARD_DEVIATION 13.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Primary Diagnosis
Bipolar disorder type I
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Primary Diagnosis
Bipolar disorder type II
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 4Population: Diagnosis of BD type I or type II by Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria, experiencing a major depressive episode (MDE).
The primary outcome was the change in score on the Montgomery-Asberg Depression Rating Scale from baseline to study end. A higher score means a worse outcome. Min value is 0, Max value is 60
Outcome measures
| Measure |
Active iTBS rTMS
n=18 Participants
The active arm involves magnetic stimulation of the brain to the left dorsolateral prefrontal cortex (DLPFC) daily for four weeks. The active arm will be receiving intermittent Theta-Burst (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to deliver magnetic pulses.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression.
|
Sham rTMS
n=19 Participants
sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
Sham rTMS: Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
|
|---|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS) Scale Score
Baseline
|
32.27 score on a scale
Standard Deviation 4.04
|
31.52 score on a scale
Standard Deviation 5.22
|
|
Montgomery Asberg Depression Rating Scale (MADRS) Scale Score
Week 2
|
24.12 score on a scale
Standard Deviation 10.09
|
25.17 score on a scale
Standard Deviation 8.24
|
|
Montgomery Asberg Depression Rating Scale (MADRS) Scale Score
Week 4
|
24.46 score on a scale
Standard Deviation 10.82
|
23.06 score on a scale
Standard Deviation 10.58
|
SECONDARY outcome
Timeframe: Baseline to Week 4 (assessed at Week 2 and Week 4, Week 4 reported)Response rates are defined as patients showing ≥50% reduction in MADRS scores.
Outcome measures
| Measure |
Active iTBS rTMS
n=18 Participants
The active arm involves magnetic stimulation of the brain to the left dorsolateral prefrontal cortex (DLPFC) daily for four weeks. The active arm will be receiving intermittent Theta-Burst (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to deliver magnetic pulses.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression.
|
Sham rTMS
n=19 Participants
sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
Sham rTMS: Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
|
|---|---|---|
|
Number of Participants With Clinical Response
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4 (assessed at Week 2 and Week 4, Week 4 reported)Clinical Remission is defined as a MADRS score ≤12
Outcome measures
| Measure |
Active iTBS rTMS
n=18 Participants
The active arm involves magnetic stimulation of the brain to the left dorsolateral prefrontal cortex (DLPFC) daily for four weeks. The active arm will be receiving intermittent Theta-Burst (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to deliver magnetic pulses.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression.
|
Sham rTMS
n=19 Participants
sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
Sham rTMS: Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
|
|---|---|---|
|
Number of Participants Meeting Criteria for Clinical Remission
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksThe visual analog scale (VAS) is a self report measure that captures the over all well being. Min 0-worse health to Max 100- best health.
Outcome measures
| Measure |
Active iTBS rTMS
n=18 Participants
The active arm involves magnetic stimulation of the brain to the left dorsolateral prefrontal cortex (DLPFC) daily for four weeks. The active arm will be receiving intermittent Theta-Burst (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to deliver magnetic pulses.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression.
|
Sham rTMS
n=19 Participants
sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
Sham rTMS: Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
|
|---|---|---|
|
Overall Well Being
Baseline
|
41.83 score on a scale
Standard Deviation 18.29
|
35.21 score on a scale
Standard Deviation 18.80
|
|
Overall Well Being
Week 4
|
58.13 score on a scale
Standard Deviation 17.13
|
46.66 score on a scale
Standard Deviation 18.09
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksPopulation: Not all participants completed the questionnaire.
Brief Illness Perception Questionnaire measures participant's perception of illness. Min = 0 Max = 80. Higher score means worse outcome.
Outcome measures
| Measure |
Active iTBS rTMS
n=17 Participants
The active arm involves magnetic stimulation of the brain to the left dorsolateral prefrontal cortex (DLPFC) daily for four weeks. The active arm will be receiving intermittent Theta-Burst (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to deliver magnetic pulses.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression.
|
Sham rTMS
n=18 Participants
sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
Sham rTMS: Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
|
|---|---|---|
|
Brief Illness Perception Questionnaire
Week 4
|
57.31 score on a scale
Standard Deviation 8.27
|
58.93 score on a scale
Standard Deviation 8.37
|
|
Brief Illness Perception Questionnaire
Baseline
|
60.35 score on a scale
Standard Deviation 4.67
|
59.13 score on a scale
Standard Deviation 8.21
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksThe Sheehan Disability Scale is a five-item, self-rated questionnaire designed to measure the extent to which a patient's disability due to an illness interferes with work/school, social life/leisure activities, and family life/home responsibilities. Each subscale score (a work disability, a social life disability, a family life disability) is combined into a single total score (sum of the non missing responses for items 1-3) representing a global impairment rating, ranging from 0 to 30, with higher scores indicative of significant functional impairment.
Outcome measures
| Measure |
Active iTBS rTMS
n=18 Participants
The active arm involves magnetic stimulation of the brain to the left dorsolateral prefrontal cortex (DLPFC) daily for four weeks. The active arm will be receiving intermittent Theta-Burst (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to deliver magnetic pulses.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression.
|
Sham rTMS
n=19 Participants
sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
Sham rTMS: Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
|
|---|---|---|
|
Sheehan Disability Scale (SDS)
Baseline
|
23.83 score on a scale
Standard Deviation 5.09
|
23.44 score on a scale
Standard Deviation 6.43
|
|
Sheehan Disability Scale (SDS)
Week 4
|
19.40 score on a scale
Standard Deviation 10.32
|
19.23 score on a scale
Standard Deviation 8.26
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksPopulation: Not all participants completed the questionnaire.
The Quality of Life in Bipolar Disorder scale is a 56 item scale which assesses 12 core and 2 optional (work and study) domains, each containing four self-report items (1: strongly disagree to 5: strongly agree). An overall score (range: 48-240) may be calculated by summing responses to the 48 items of the core 12 domains. Higher scores reflect greater satisfaction with a person's quality of life.
Outcome measures
| Measure |
Active iTBS rTMS
n=18 Participants
The active arm involves magnetic stimulation of the brain to the left dorsolateral prefrontal cortex (DLPFC) daily for four weeks. The active arm will be receiving intermittent Theta-Burst (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to deliver magnetic pulses.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression.
|
Sham rTMS
n=19 Participants
sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
Sham rTMS: Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
|
|---|---|---|
|
Quality of Life Questionnaire
Baseline
|
109 score on a scale
Standard Deviation 18.67
|
108.78 score on a scale
Standard Deviation 26.34
|
|
Quality of Life Questionnaire
Week 4
|
136.18 score on a scale
Standard Deviation 33.81
|
130.76 score on a scale
Standard Deviation 36.54
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksPopulation: Not all participants completed the scale at Week 4.
Patient Global Impression Rating Scale: Severity rates how depressed the participant is at the current time. 1-4 (1 is normal and 4 is severe)
Outcome measures
| Measure |
Active iTBS rTMS
n=18 Participants
The active arm involves magnetic stimulation of the brain to the left dorsolateral prefrontal cortex (DLPFC) daily for four weeks. The active arm will be receiving intermittent Theta-Burst (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to deliver magnetic pulses.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression.
|
Sham rTMS
n=18 Participants
sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
Sham rTMS: Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
|
|---|---|---|
|
Patient Global Impression Rating Scale: Severity
Week 4
|
2.60 score on a scale
Standard Deviation 0.82
|
2.66 score on a scale
Standard Deviation 0.81
|
|
Patient Global Impression Rating Scale: Severity
Baseline
|
3.16 score on a scale
Standard Deviation 0.51
|
3.05 score on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Week 4Population: Not all participants completed the scale.
Rates current depression compared to baseline. Min =1 Max =7 Higher scores mean worse outcome.
Outcome measures
| Measure |
Active iTBS rTMS
n=15 Participants
The active arm involves magnetic stimulation of the brain to the left dorsolateral prefrontal cortex (DLPFC) daily for four weeks. The active arm will be receiving intermittent Theta-Burst (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to deliver magnetic pulses.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression.
|
Sham rTMS
n=15 Participants
sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
Sham rTMS: Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
|
|---|---|---|
|
Patient Global Impression Rating Scale- Improvement
|
3.53 score on a scale
Standard Deviation 1.24
|
3.20 score on a scale
Standard Deviation 1.26
|
Adverse Events
Active iTBS rTMS
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Sham rTMS
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active iTBS rTMS
n=7 participants at risk；n=18 participants at risk
The active arm involves magnetic stimulation of the brain to the left dorsolateral prefrontal cortex (DLPFC) daily for four weeks. The active arm will be receiving intermittent Theta-Burst (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to deliver magnetic pulses.
iTBS repetitive Transcranial Magnetic Stimulation (rTMS): rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression.
|
Sham rTMS
n=9 participants at risk；n=19 participants at risk
sham rTMS treatment involves scalp stimulation with no magnetic pulse daily for four weeks (20 sessions). Sham rTMS involves only the click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
Sham rTMS: Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
|
|---|---|---|
|
Nervous system disorders
Pain and discomfort at treatment site
|
57.1%
4/7 • Number of events 4 • Baseline to 4 weeks
Systematic collection of Non-Serious Adverse events occurred only at the DMCBH site in Vancouver.
|
22.2%
2/9 • Number of events 2 • Baseline to 4 weeks
Systematic collection of Non-Serious Adverse events occurred only at the DMCBH site in Vancouver.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
0.00%
0/7 • Baseline to 4 weeks
Systematic collection of Non-Serious Adverse events occurred only at the DMCBH site in Vancouver.
|
22.2%
2/9 • Number of events 2 • Baseline to 4 weeks
Systematic collection of Non-Serious Adverse events occurred only at the DMCBH site in Vancouver.
|
|
Nervous system disorders
Headache
|
71.4%
5/7 • Number of events 5 • Baseline to 4 weeks
Systematic collection of Non-Serious Adverse events occurred only at the DMCBH site in Vancouver.
|
44.4%
4/9 • Number of events 4 • Baseline to 4 weeks
Systematic collection of Non-Serious Adverse events occurred only at the DMCBH site in Vancouver.
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Number of events 1 • Baseline to 4 weeks
Systematic collection of Non-Serious Adverse events occurred only at the DMCBH site in Vancouver.
|
22.2%
2/9 • Number of events 2 • Baseline to 4 weeks
Systematic collection of Non-Serious Adverse events occurred only at the DMCBH site in Vancouver.
|
|
General disorders
Fatigue
|
71.4%
5/7 • Number of events 5 • Baseline to 4 weeks
Systematic collection of Non-Serious Adverse events occurred only at the DMCBH site in Vancouver.
|
44.4%
4/9 • Number of events 4 • Baseline to 4 weeks
Systematic collection of Non-Serious Adverse events occurred only at the DMCBH site in Vancouver.
|
|
Gastrointestinal disorders
Stomach Cramp/ Diarrhea
|
0.00%
0/7 • Baseline to 4 weeks
Systematic collection of Non-Serious Adverse events occurred only at the DMCBH site in Vancouver.
|
22.2%
2/9 • Number of events 2 • Baseline to 4 weeks
Systematic collection of Non-Serious Adverse events occurred only at the DMCBH site in Vancouver.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place