Trial Outcomes & Findings for Dysport for the Treatment of OMD (NCT NCT01921270)
NCT ID: NCT01921270
Last Updated: 2017-11-17
Results Overview
This scale measures the severity of dystonia for the jaw and tongue by a blinded rater. Dystonia is rated from 0 to 10: 0=No dystonia present, 1=Minimal dystonia, 5=Moderate dystonia,10=Most severe dystonia
COMPLETED
PHASE1/PHASE2
18 participants
Baseline, Week 6, Week 12
2017-11-17
Participant Flow
Participant milestones
| Measure |
Dysport Injections
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Dysport Injections
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dysport Injections
n=18 Participants
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections.
Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Age, Continuous
|
62.83 years
STANDARD_DEVIATION 10.45 • n=18 Participants
|
|
Sex: Female, Male
Female
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12 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=18 Participants
|
|
Region of Enrollment
United States
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18 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
This scale measures the severity of dystonia for the jaw and tongue by a blinded rater. Dystonia is rated from 0 to 10: 0=No dystonia present, 1=Minimal dystonia, 5=Moderate dystonia,10=Most severe dystonia
Outcome measures
| Measure |
Dysport Injections
n=18 Participants
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater
Baseline
|
3.80 units on a scale
Standard Deviation 2.29
|
|
Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater
Week 6
|
3.57 units on a scale
Standard Deviation 2.05
|
|
Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater
Week 12
|
3.71 units on a scale
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Data were not collected.
Measure of jaw pain by visual analogue scale (0-100) where 0 represents "no pain" and 100 represents the "most severe pain".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
The SCS-PD measures drooling. Individual items are scored on a scale from 0-3 where 0 represents "never" and 3 represents "always". The overall maximum score is 21. A higher score indicates greater drooling severity. A lower score indicates lesser severity.
Outcome measures
| Measure |
Dysport Injections
n=18 Participants
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score
Baseline
|
3.00 units on a scale
Standard Deviation 3.91
|
|
Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score
Week 6
|
2.72 units on a scale
Standard Deviation 4.28
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|
Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score
Week 12
|
2.53 units on a scale
Standard Deviation 3.20
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SECONDARY outcome
Timeframe: Baseline, Week 12Population: Data were not collected.
The patient will be asked to estimate how many times they tend to accidentally/involuntarily bite their tongue per day.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
Ease of chewing and swallowing will be assessed by the SDQ-20 (modified to exclude question 5 due to redundancy as it relates to drooling and question 15 which is not relevant to the study as it involves prior aspiration pneumonias). Individual items are scored from 0 (never) to 3 (very frequently). The overall score is the total for all items; a higher score indicating more frequent swallowing disturbance; a lower score indicating no or less frequent disturbance, with a possible maximum score of 39.
Outcome measures
| Measure |
Dysport Injections
n=18 Participants
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Mean Swallowing Disturbance Questionnaire (SDQ-20) Score
Baseline
|
13.17 units on a scale
Standard Deviation 9.51
|
|
Mean Swallowing Disturbance Questionnaire (SDQ-20) Score
Week 6
|
15.61 units on a scale
Standard Deviation 8.56
|
|
Mean Swallowing Disturbance Questionnaire (SDQ-20) Score
Week 12
|
13.29 units on a scale
Standard Deviation 8.54
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
The Fahn-Marsden Part B "Speech" Question assesses the ease of producing speech. Responses range from 0=Normal, 1=Slightly involved, easily understood, 2=Some difficulty understanding, 3=Marked difficulty understanding.
Outcome measures
| Measure |
Dysport Injections
n=18 Participants
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Mean Fahn-Marsden Part B "Speech" Question (BFM-q21) Rating
Baseline
|
1.33 units on a scale
Standard Deviation .91
|
|
Mean Fahn-Marsden Part B "Speech" Question (BFM-q21) Rating
Week 6
|
.94 units on a scale
Standard Deviation .87
|
|
Mean Fahn-Marsden Part B "Speech" Question (BFM-q21) Rating
Week 12
|
.94 units on a scale
Standard Deviation .75
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
The OMDQ-25 is a subjective quality of life measurement made for patients with Oromandibular Dystonia. The maximum total score is 100 indicating the highest quality of life. A score of 50 indicates a mediocre quality of life. A lower score indicates perceived lower quality of life.
Outcome measures
| Measure |
Dysport Injections
n=18 Participants
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Mean Oromandibular Dystonia Quality of Life Questionnaire (OMDQ-25) Score
Baseline
|
47.39 units on a scale
Standard Deviation 23.00
|
|
Mean Oromandibular Dystonia Quality of Life Questionnaire (OMDQ-25) Score
Week 6
|
43.22 units on a scale
Standard Deviation 23.24
|
|
Mean Oromandibular Dystonia Quality of Life Questionnaire (OMDQ-25) Score
Week 12
|
38.00 units on a scale
Standard Deviation 21.42
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SECONDARY outcome
Timeframe: Week 6, Week 12Population: Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Responses are scored on a scale from 1 to 7; 1 represents "very much improved" and 7 represents "very much worse".
Outcome measures
| Measure |
Dysport Injections
n=18 Participants
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Mean Global Clinical Impression - Improvement Scale (CGI) Index Score
Week 6
|
2.89 units on a scale
Standard Deviation 1.28
|
|
Mean Global Clinical Impression - Improvement Scale (CGI) Index Score
Week 12
|
2.53 units on a scale
Standard Deviation .87
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Responses are scored on a scale from 1 to 7; 1 represents "normal, not at all ill" and 7 represents "among the most extremely ill patients".
Outcome measures
| Measure |
Dysport Injections
n=18 Participants
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Mean Global Clinical Impression Scale (CGI-S) With Severity Index Score
Baseline
|
4.06 units on a scale
Standard Error 1.00
|
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Mean Global Clinical Impression Scale (CGI-S) With Severity Index Score
Week 6
|
3.22 units on a scale
Standard Error 1.11
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|
Mean Global Clinical Impression Scale (CGI-S) With Severity Index Score
Week 12
|
3.29 units on a scale
Standard Error .92
|
SECONDARY outcome
Timeframe: Week 6, Week 12Population: Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
The Clinical Global Impression - Efficacy Index is a 4×4 rating scale that assesses the therapeutic effect of treatment. Responses range on a scale from 0 to 4 with 4 being the best response.
Outcome measures
| Measure |
Dysport Injections
n=18 Participants
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Mean Global Clinical Impression- Efficacy Index Score
Week 6
|
1.51 units on a scale
Standard Deviation .93
|
|
Mean Global Clinical Impression- Efficacy Index Score
Week 12
|
1.93 units on a scale
Standard Deviation .97
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
The UDRS measures dystonia severity. The UDRS is being rated by un-blinded video evaluators regarding severity of subject's dystonia. Scores range from 0 to 10; 0 indicating no dystonia, 5 indicating moderate dystonia, and 10 indicating the worst dystonia.
Outcome measures
| Measure |
Dysport Injections
n=18 Participants
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Un-blinded Rater
Baseline
|
4.67 units on a scale
Standard Deviation 1.15
|
|
Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Un-blinded Rater
Week 6
|
3.47 units on a scale
Standard Deviation 1.58
|
|
Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Un-blinded Rater
Week 12
|
3.26 units on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
This scale measures the severity of dystonia for the jaw and tongue by an un-blinded rater. Dystonia is rated from 0 to 10: 0=No dystonia present, 1=Minimal dystonia, 5=Moderate dystonia,10=Most severe dystonia
Outcome measures
| Measure |
Dysport Injections
n=18 Participants
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Mean Global Dystonia Rating Scale Score as Measured by Un-blinded Rater
Baseline
|
5.67 units on a scale
Standard Deviation 1.53
|
|
Mean Global Dystonia Rating Scale Score as Measured by Un-blinded Rater
Week 6
|
3.94 units on a scale
Standard Deviation 2.10
|
|
Mean Global Dystonia Rating Scale Score as Measured by Un-blinded Rater
Week 12
|
3.76 units on a scale
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12Population: Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.
The UDRS measures dystonia severity. The UDRS is being rated by blinded video evaluators regarding severity of subject's dystonia. Scores range from 0 to 10; 0 indicating no dystonia, 5 indicating moderate dystonia, and 10 indicating the worst dystonia.
Outcome measures
| Measure |
Dysport Injections
n=18 Participants
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Blinded Rater
Baseline
|
3.50 units on a scale
Standard Deviation 1.92
|
|
Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Blinded Rater
Week 6
|
3.47 units on a scale
Standard Deviation 1.79
|
|
Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Blinded Rater
Week 12
|
3.30 units on a scale
Standard Deviation 1.72
|
Adverse Events
Dysport Injections
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dysport Injections
n=18 participants at risk
Participants with OMD who have been previously treated with any botulinum toxin Type A were injected with Dysport®.
Low Dose - AbobotulinumtoxinA: Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
Muscles that may be included for in injection for OMD with Jaw Closing:
Medial Pterygoid 50 units, Masseter 25 units
Muscles that may be included in injection for OMD with Jaw Opening:
Lateral Pterygoid 50 units, Anterior digastrics 10 units
Muscle that will be included in injection for OMD with Tongue Protrusion:
Genioglossus 7.5 units
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
6/18 • Number of events 6 • Adverse events were collected throughout the duration of the study (4 years).
|
|
Nervous system disorders
Change in Speech
|
27.8%
5/18 • Number of events 5 • Adverse events were collected throughout the duration of the study (4 years).
|
|
Nervous system disorders
Soft Palate Weakness
|
22.2%
4/18 • Number of events 4 • Adverse events were collected throughout the duration of the study (4 years).
|
|
Metabolism and nutrition disorders
Xerostomia
|
22.2%
4/18 • Number of events 4 • Adverse events were collected throughout the duration of the study (4 years).
|
|
Gastrointestinal disorders
Throat Tightness/Congestion
|
16.7%
3/18 • Number of events 3 • Adverse events were collected throughout the duration of the study (4 years).
|
|
Metabolism and nutrition disorders
Drooling
|
16.7%
3/18 • Number of events 3 • Adverse events were collected throughout the duration of the study (4 years).
|
|
Metabolism and nutrition disorders
Difficulty Chewing
|
11.1%
2/18 • Number of events 2 • Adverse events were collected throughout the duration of the study (4 years).
|
|
Metabolism and nutrition disorders
Food Falling Out of Mouth
|
11.1%
2/18 • Number of events 2 • Adverse events were collected throughout the duration of the study (4 years).
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
11.1%
2/18 • Number of events 2 • Adverse events were collected throughout the duration of the study (4 years).
|
|
Investigations
Weight Loss
|
11.1%
2/18 • Number of events 2 • Adverse events were collected throughout the duration of the study (4 years).
|
|
General disorders
Flu-like Symptoms
|
11.1%
2/18 • Number of events 2 • Adverse events were collected throughout the duration of the study (4 years).
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • Number of events 2 • Adverse events were collected throughout the duration of the study (4 years).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place