Trial Outcomes & Findings for Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD (NCT NCT01793610)
NCT ID: NCT01793610
Last Updated: 2025-06-05
Results Overview
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint)
Results posted on
2025-06-05
Participant Flow
Candidates were recruited via Internet advertisements and referrals from mental health professionals.
Participant milestones
| Measure |
Comparator Dose MDMA (40 mg) and Psychotherapy
Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
|
Active Dose 2 MDMA (100 mg) and Psychotherapy
Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
|
Active Dose 1 MDMA (125 mg) and Psychotherapy
Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
|
|---|---|---|---|
|
Stage 1 Randomized, Double-blind Period
STARTED
|
6
|
9
|
13
|
|
Stage 1 Randomized, Double-blind Period
COMPLETED
|
6
|
9
|
12
|
|
Stage 1 Randomized, Double-blind Period
NOT COMPLETED
|
0
|
0
|
1
|
|
Stage 2 Open-Label Crossover Period
STARTED
|
5
|
0
|
0
|
|
Stage 2 Open-Label Crossover Period
COMPLETED
|
5
|
0
|
0
|
|
Stage 2 Open-Label Crossover Period
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD
Baseline characteristics by cohort
| Measure |
Active Dose 1 MDMA (125 mg) and Psychotherapy
n=12 Participants
Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
|
Active Dose 2 MDMA (100 mg) and Psychotherapy
n=9 Participants
Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
|
Comparator-dose MDMA (40 mg) and Psychotherapy
n=6 Participants
Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 15.53 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
40 years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
42.4 years
STANDARD_DEVIATION 12.93 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian Or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint)Population: Modified Intent-to-Treat set (mITT), Stage 1 participants
The Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-IV. It contains symptom subscales, a CAPS-IV total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.
Outcome measures
| Measure |
Active Dose 1 (125 mg) MDMA and Psychotherapy
n=12 Participants
Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
|
Active Dose 2 (100 mg) MDMA and Psychotherapy
n=9 Participants
Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
|
Comparator-dose (40 mg) MDMA and Psychotherapy
n=6 Participants
Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
|
|---|---|---|---|
|
Change in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) Total Severity Score From Baseline to One Month Post 2nd Experimental Session
|
-26.3 score on a scale
Standard Deviation 29.52
|
-24.4 score on a scale
Standard Deviation 24.22
|
-11.5 score on a scale
Standard Deviation 21.21
|
SECONDARY outcome
Timeframe: Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint)Population: Modified Intent-to-Treat set (mITT), Stage 1 participants
The PTSD Diagnostic Scale (PSD) is self-report measure designed to follow DSM-IV criteria for assessing PTSD. It contains 49 items, with responses made on a four-point scale, ranging from 0 ("not at all") to 3 ("five or more times a week"). The PDS consists of a list of 12 potential traumatic events, 12 items addressing elements of the traumatic event, 17 symptom items, and 9 items assessing impact on areas of life function. Items addressing elements of the traumatic event and life function are answered as either present or not present (Yes or No). The 17 items are summed to create a symptom severity score, with higher scores indicating a greater number and/or intensity of PTSD symptoms. The symptom severity score ranges from 0 to 51.
Outcome measures
| Measure |
Active Dose 1 (125 mg) MDMA and Psychotherapy
n=12 Participants
Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
|
Active Dose 2 (100 mg) MDMA and Psychotherapy
n=9 Participants
Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
|
Comparator-dose (40 mg) MDMA and Psychotherapy
n=6 Participants
Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
|
|---|---|---|---|
|
Change in PTSD Diagnostic Scale (PDS) From Baseline to One Month Post 2nd Experimental Session
|
-11.3 score on a scale
Standard Deviation 11.26
|
-10.0 score on a scale
Standard Deviation 10.44
|
-4.2 score on a scale
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint)Population: Modified Intent-to-Treat set (mITT), Stage 1 participants
Validated self-report measure of symptoms of depression. The BDI-II total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depressive symptoms. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.
Outcome measures
| Measure |
Active Dose 1 (125 mg) MDMA and Psychotherapy
n=12 Participants
Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
|
Active Dose 2 (100 mg) MDMA and Psychotherapy
n=9 Participants
Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
|
Comparator-dose (40 mg) MDMA and Psychotherapy
n=6 Participants
Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
|
|---|---|---|---|
|
Change in Beck Depression Inventory II (BDI-II) From Baseline to One Month Post 2nd Experimental Session
|
-11.0 score on a scale
Standard Deviation 13.68
|
-9.9 score on a scale
Standard Deviation 13.26
|
-11.5 score on a scale
Standard Deviation 7.79
|
SECONDARY outcome
Timeframe: Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint)Population: Modified Intent-to-Treat set (mITT), Stage 1 participants
The Global Assessment of Functioning (GAF) Scale is a numeric scale ranging from 0 through 100 that is used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults. Higher scores indicate better functioning.
Outcome measures
| Measure |
Active Dose 1 (125 mg) MDMA and Psychotherapy
n=12 Participants
Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
|
Active Dose 2 (100 mg) MDMA and Psychotherapy
n=9 Participants
Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
|
Comparator-dose (40 mg) MDMA and Psychotherapy
n=6 Participants
Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
|
|---|---|---|---|
|
Change in Global Assessment of Functioning (GAF) Total Score From Baseline to One Month Post 2nd Experimental Session
|
0.6 score on a scale
Standard Deviation 10.57
|
2.4 score on a scale
Standard Deviation 9.63
|
1.5 score on a scale
Standard Deviation 4.59
|
SECONDARY outcome
Timeframe: Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint)Population: Modified Intent-to-Treat set (mITT), Stage 1 participants
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances. It is comprised of 18 items that yield seven component scores. Component scores are summed to create a total score. Total scores range from 0 (better) to 21 (worse), with higher scores indicating poor sleep quality.
Outcome measures
| Measure |
Active Dose 1 (125 mg) MDMA and Psychotherapy
n=12 Participants
Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
|
Active Dose 2 (100 mg) MDMA and Psychotherapy
n=9 Participants
Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
|
Comparator-dose (40 mg) MDMA and Psychotherapy
n=6 Participants
Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
|
|---|---|---|---|
|
Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to One Month Post 2nd Experimental Session
|
-2.0 score on a scale
Standard Deviation 4.69
|
-3.6 score on a scale
Standard Deviation 6.19
|
-0.8 score on a scale
Standard Deviation 2.48
|
SECONDARY outcome
Timeframe: Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint)Population: Modified Intent-to-Treat set (mITT), Stage 1 participants
The DES-II is a 28-item self-report measure of dissociation, defined as a lack of normal integration of an individual's thoughts, feelings, or experiences into the stream of consciousness or memory. The scale consists of statements describing facets of dissociation. Respondents indicate how often the specific experience happens to them, from "never" to "always." The DES-II uses the same items but with responses made on a 10 point scale from "0%" to "100%" of the time. The scale is scored by treating percentages as single digits to produce a total score with higher scores indicating greater severity. The total score ranges from 0 to 100.
Outcome measures
| Measure |
Active Dose 1 (125 mg) MDMA and Psychotherapy
n=12 Participants
Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
|
Active Dose 2 (100 mg) MDMA and Psychotherapy
n=9 Participants
Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
|
Comparator-dose (40 mg) MDMA and Psychotherapy
n=6 Participants
Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
|
|---|---|---|---|
|
Change in Dissociative Experiences Scale (DES-II) From Baseline to One Month Post 2nd Experimental Session
|
-5.9 score on a scale
Standard Deviation 11.98
|
-13.3 score on a scale
Standard Deviation 15.25
|
-0.2 score on a scale
Standard Deviation 6.95
|
SECONDARY outcome
Timeframe: Baseline Enrollment to 1-Month Post 2nd Experimental Session (Stage 1 Primary Endpoint)Population: Modified Intent-to-Treat set (mITT), Stage 1 participants. 1 Comparator Dose participant did not complete a baseline PTGI assessment so is excluded from this analysis.
The PTGI is a 21-item self-report measure of perceived growth or benefits occurring after a traumatic event. It contains five subscales: relationship to others, new possibilities, personal strength, spiritual change, and appreciation of life. PTGI scores on a 6 point scale are: 0 - I did not experience this as a result of my crisis; 1 - I experienced this change to a very small degree as a result of my crisis; 2 - I experienced this change to a small degree as a result of my crisis; 3 - I experienced this change to a moderate degree as a result of my crisis; 4 - I experienced this change to a great degree as a result of my crisis; and 5 - I experienced this change to a very great degree as a result of my crisis. A total score is calculated by summing the responses to all 21 items, each rated on a 6-point scale, with higher scores indicating greater post-traumatic growth
Outcome measures
| Measure |
Active Dose 1 (125 mg) MDMA and Psychotherapy
n=10 Participants
Participants receive an initial dose of 125 mg of MDMA orally, with an optional supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
|
Active Dose 2 (100 mg) MDMA and Psychotherapy
n=9 Participants
Participants receive an initial dose of 100 mg of MDMA orally, with an optional supplemental dose of 50 mg MDMA 1.5 to 2.5 hours later.
|
Comparator-dose (40 mg) MDMA and Psychotherapy
n=5 Participants
Participants receive an initial dose of 40 mg of MDMA orally, with an optional supplemental dose of 20 mg MDMA 1.5 to 2.5 hours later.
|
|---|---|---|---|
|
Change in Posttraumatic Growth Inventory (PTGI) From Baseline to One Month Post 2nd Experimental Session
|
15.0 score on a scale
Standard Deviation 19.71
|
16.2 score on a scale
Standard Deviation 29.47
|
3.8 score on a scale
Standard Deviation 24.65
|
Adverse Events
Active Dose 1 MDMA (125 mg) and Psychotherapy (Stage 1)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Active Dose 2 MDMA (100 mg) and Psychotherapy (Stage 1)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Comparator-dose MDMA (40 mg) and Psychotherapy (Stage 1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Open-Label Session: Active Dose 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Open-Label Session: Active Dose 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Crossover Open-Label Sessions: Comparator Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
12 Month Follow-up: Active Dose 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
12 Month Follow-up: Active Dose 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
12 Month Follow-up: Comparator Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SRRs: Active Dose 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SRRs: Active Dose 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SRRs: Comparator
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Dose 1 MDMA (125 mg) and Psychotherapy (Stage 1)
n=13 participants at risk
Participants receive an initial dose of 125 mg of midomafetamine HCl orally, with an optional supplemental dose of 62.5 mg 1.5 to 2.5 hours later during two blinded sessions.
|
Active Dose 2 MDMA (100 mg) and Psychotherapy (Stage 1)
n=9 participants at risk
Participants receive an initial dose of 100 mg of midomafetamine HCl orally, with an optional supplemental dose of 50 mg 1.5 to 2.5 hours later during two blinded sessions.
|
Comparator-dose MDMA (40 mg) and Psychotherapy (Stage 1)
n=6 participants at risk
Participants receive an initial dose of 40 mg of midomafetamine HCl orally, with an optional supplemental dose of 20 mg 1.5 to 2.5 hours later during two blinded sessions.
|
Open-Label Session: Active Dose 1
n=12 participants at risk
Participants will receive one open-label MDMA-assisted therapy session with an initial dose of 125 mg of midomafetamine HCl orally, with an optional supplemental dose of 62.5 mg 1.5 to 2.5 hours later.
|
Open-Label Session: Active Dose 2
n=9 participants at risk
Participants will receive one open-label MDMA-assisted therapy session with an initial dose of 100 mg of midomafetamine HCl orally, with an optional supplemental dose of 62.5 mg 1.5 to 2.5 hours later.
|
Crossover Open-Label Sessions: Comparator Dose
n=5 participants at risk
Participants who received the comparator dose during Stage 1 will have the opportunity to crossover and take part in a second study segment, referred to as Stage 2, with three open-label MDMA-assisted therapy sessions.
In the first session, the dose will be 100 mg followed 1.5 to 2.5 hours later by an optional supplement dose of 50 mg.
In the second and third sessions, participants will have the option to keep the same dose or titrate up to 125 mg, followed 1.5 to 2.5 hours later by 62.5 mg.
|
12 Month Follow-up: Active Dose 1
n=11 participants at risk
Adverse events collected 12 months after the participant's final MDMA-assisted therapy session.
|
12 Month Follow-up: Active Dose 2
n=9 participants at risk
Adverse events collected 12 months after the participant's final MDMA-assisted therapy session.
|
12 Month Follow-up: Comparator Dose
n=5 participants at risk
Adverse events collected 12 months after the participant's final MDMA-assisted therapy session (following crossover to receive 3 additional treatment sessions with active dose).
|
SRRs: Active Dose 1
n=13 participants at risk
Spontaneously reported reactions (SRRs) on open-label experimental sessions days and 7 days after.
|
SRRs: Active Dose 2
n=9 participants at risk
Spontaneously reported reactions (SRRs) on open-label experimental sessions days and 7 days after.
|
SRRs: Comparator
n=6 participants at risk
Spontaneously reported reactions (SRRs) on open-label experimental sessions days and 7 days after.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ruptured ovarian cyst
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
Other adverse events
| Measure |
Active Dose 1 MDMA (125 mg) and Psychotherapy (Stage 1)
n=13 participants at risk
Participants receive an initial dose of 125 mg of midomafetamine HCl orally, with an optional supplemental dose of 62.5 mg 1.5 to 2.5 hours later during two blinded sessions.
|
Active Dose 2 MDMA (100 mg) and Psychotherapy (Stage 1)
n=9 participants at risk
Participants receive an initial dose of 100 mg of midomafetamine HCl orally, with an optional supplemental dose of 50 mg 1.5 to 2.5 hours later during two blinded sessions.
|
Comparator-dose MDMA (40 mg) and Psychotherapy (Stage 1)
n=6 participants at risk
Participants receive an initial dose of 40 mg of midomafetamine HCl orally, with an optional supplemental dose of 20 mg 1.5 to 2.5 hours later during two blinded sessions.
|
Open-Label Session: Active Dose 1
n=12 participants at risk
Participants will receive one open-label MDMA-assisted therapy session with an initial dose of 125 mg of midomafetamine HCl orally, with an optional supplemental dose of 62.5 mg 1.5 to 2.5 hours later.
|
Open-Label Session: Active Dose 2
n=9 participants at risk
Participants will receive one open-label MDMA-assisted therapy session with an initial dose of 100 mg of midomafetamine HCl orally, with an optional supplemental dose of 62.5 mg 1.5 to 2.5 hours later.
|
Crossover Open-Label Sessions: Comparator Dose
n=5 participants at risk
Participants who received the comparator dose during Stage 1 will have the opportunity to crossover and take part in a second study segment, referred to as Stage 2, with three open-label MDMA-assisted therapy sessions.
In the first session, the dose will be 100 mg followed 1.5 to 2.5 hours later by an optional supplement dose of 50 mg.
In the second and third sessions, participants will have the option to keep the same dose or titrate up to 125 mg, followed 1.5 to 2.5 hours later by 62.5 mg.
|
12 Month Follow-up: Active Dose 1
n=11 participants at risk
Adverse events collected 12 months after the participant's final MDMA-assisted therapy session.
|
12 Month Follow-up: Active Dose 2
n=9 participants at risk
Adverse events collected 12 months after the participant's final MDMA-assisted therapy session.
|
12 Month Follow-up: Comparator Dose
n=5 participants at risk
Adverse events collected 12 months after the participant's final MDMA-assisted therapy session (following crossover to receive 3 additional treatment sessions with active dose).
|
SRRs: Active Dose 1
n=13 participants at risk
Spontaneously reported reactions (SRRs) on open-label experimental sessions days and 7 days after.
|
SRRs: Active Dose 2
n=9 participants at risk
Spontaneously reported reactions (SRRs) on open-label experimental sessions days and 7 days after.
|
SRRs: Comparator
n=6 participants at risk
Spontaneously reported reactions (SRRs) on open-label experimental sessions days and 7 days after.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
1/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Feeling abnormal
|
7.7%
1/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
1/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Malaise
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Nervous system disorders
Migraine
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Psychiatric disorders
Depressed mood
|
7.7%
1/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Psychiatric disorders
Irritability
|
7.7%
1/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
22.2%
2/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Psychiatric disorders
Obsessive rumination
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
8.3%
1/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
20.0%
1/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Psychiatric disorders
Anxiety
|
23.1%
3/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
33.3%
3/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
9.1%
1/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
20.0%
1/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
100.0%
5/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Headache
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
40.0%
2/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Metabolism and nutrition disorders
Nausea
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Pain
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
16.7%
1/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Pyrexia
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
16.7%
1/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
8.3%
1/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
7.7%
1/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
16.7%
2/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Psychiatric disorders
Panic attack
|
7.7%
1/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
9.1%
1/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
8.3%
1/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
20.0%
1/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
20.0%
1/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Eye disorders
Vision blurred
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
20.0%
1/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
20.0%
1/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
9.1%
1/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
9.1%
1/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
9.1%
1/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
11.1%
1/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Difficulty Concentrating
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
40.0%
2/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Drowsiness
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
20.0%
1/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Fatigue
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
40.0%
2/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Impaired Judgment
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
20.0%
1/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Insomnia
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
60.0%
3/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Jaw Clenching, Tight Jaw
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
40.0%
2/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Lack of Appetite
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
20.0%
1/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Low mood
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
40.0%
2/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Muscle tension
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
20.0%
1/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Need more sleep
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
40.0%
2/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Perspiration
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
20.0%
1/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
|
General disorders
Ruminations
|
0.00%
0/13 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/6 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/11 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/12 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
0.00%
0/9 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
40.0%
2/5 • All AEs from baseline to long-term follow-up (approximately 18 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place