Trial Outcomes & Findings for Natural History Study in Adult-Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia (NCT NCT05020743)
NCT ID: NCT05020743
Last Updated: 2025-08-13
Results Overview
Change from Baseline in ventricle volume at Month 6
Recruitment status
TERMINATED
Target enrollment
56 participants
Primary outcome timeframe
Month 6
Results posted on
2025-08-13
Participant Flow
This study was conducted at 11 sites that screened participants in the United States, Canada, Netherlands, United Kingdom, Germany, and Brazil. The first participant was enrolled on September 13, 2021 and the last participant was enrolled on April 23, 2025.
Of 82 screened patients, 26 failed to meet eligibility criteria. Of 56 participants enrolled in the study, 53 were enrolled prior to the data cutoff of February 19, 2025.
Participant milestones
| Measure |
Prodromal
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP, and who had none or up to and including 2 ALSP-related clinical signs or symptoms.
|
Symptomatic/Definitive ALSP (no HSCT)
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and did not have hematopoietic stem cell transplant (HSCT) procedure.
|
Symptomatic/Definitive ALSP (Prior HSCT)
ALSP participants with CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and had prior hematopoietic stem cell transplant (HSCT) procedure.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
23
|
11
|
|
Overall Study
COMPLETED
|
6
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
23
|
11
|
Reasons for withdrawal
| Measure |
Prodromal
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP, and who had none or up to and including 2 ALSP-related clinical signs or symptoms.
|
Symptomatic/Definitive ALSP (no HSCT)
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and did not have hematopoietic stem cell transplant (HSCT) procedure.
|
Symptomatic/Definitive ALSP (Prior HSCT)
ALSP participants with CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and had prior hematopoietic stem cell transplant (HSCT) procedure.
|
|---|---|---|---|
|
Overall Study
Enrollment in Interventional Study
|
2
|
9
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Study Termination by Sponsor
|
10
|
11
|
10
|
Baseline Characteristics
9 prodromal and 1 symptomatic/definitive ALSP (no HSCT) subjects had unknown age of diagnosis.
Baseline characteristics by cohort
| Measure |
Prodromal
n=19 Participants
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP, and who had none or up to and including 2 ALSP-related clinical signs or symptoms.
|
Symptomatic/Definitive ALSP (no HSCT)
n=23 Participants
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and did not have hematopoietic stem cell transplant (HSCT) procedure.
|
Symptomatic/Definitive ALSP (Prior HSCT)
n=11 Participants
ALSP participants with CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and had prior hematopoietic stem cell transplant (HSCT) procedure.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 16.62 • n=19 Participants
|
44.5 years
STANDARD_DEVIATION 11.54 • n=23 Participants
|
47.5 years
STANDARD_DEVIATION 4.55 • n=11 Participants
|
45.4 years
STANDARD_DEVIATION 12.54 • n=53 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=19 Participants
|
15 Participants
n=23 Participants
|
4 Participants
n=11 Participants
|
31 Participants
n=53 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=19 Participants
|
8 Participants
n=23 Participants
|
7 Participants
n=11 Participants
|
22 Participants
n=53 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=19 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=19 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=19 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=19 Participants
|
3 Participants
n=23 Participants
|
0 Participants
n=11 Participants
|
4 Participants
n=53 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=19 Participants
|
19 Participants
n=23 Participants
|
10 Participants
n=11 Participants
|
47 Participants
n=53 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=19 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=19 Participants
|
6 Participants
n=23 Participants
|
1 Participants
n=11 Participants
|
9 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=19 Participants
|
16 Participants
n=23 Participants
|
10 Participants
n=11 Participants
|
43 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=19 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=53 Participants
|
|
Age at Diagnosis
|
45.0 years
STANDARD_DEVIATION 15.00 • n=10 Participants • 9 prodromal and 1 symptomatic/definitive ALSP (no HSCT) subjects had unknown age of diagnosis.
|
43.6 years
STANDARD_DEVIATION 11.18 • n=22 Participants • 9 prodromal and 1 symptomatic/definitive ALSP (no HSCT) subjects had unknown age of diagnosis.
|
43.9 years
STANDARD_DEVIATION 4.60 • n=11 Participants • 9 prodromal and 1 symptomatic/definitive ALSP (no HSCT) subjects had unknown age of diagnosis.
|
44.0 years
STANDARD_DEVIATION 10.78 • n=43 Participants • 9 prodromal and 1 symptomatic/definitive ALSP (no HSCT) subjects had unknown age of diagnosis.
|
|
Duration Since Diagnosis
|
1.1 years
STANDARD_DEVIATION 1.29 • n=10 Participants • 9 prodromal and 1 symptomatic/definitive ALSP (no HSCT) subjects had unknown age of diagnosis.
|
1.0 years
STANDARD_DEVIATION 1.40 • n=22 Participants • 9 prodromal and 1 symptomatic/definitive ALSP (no HSCT) subjects had unknown age of diagnosis.
|
4.1 years
STANDARD_DEVIATION 1.46 • n=11 Participants • 9 prodromal and 1 symptomatic/definitive ALSP (no HSCT) subjects had unknown age of diagnosis.
|
1.8 years
STANDARD_DEVIATION 1.92 • n=43 Participants • 9 prodromal and 1 symptomatic/definitive ALSP (no HSCT) subjects had unknown age of diagnosis.
|
PRIMARY outcome
Timeframe: Month 6Population: Not all participants completed Month 6 visit prior to data cutoff.
Change from Baseline in ventricle volume at Month 6
Outcome measures
| Measure |
Prodromal
n=18 Participants
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP, and who had none or up to and including 2 ALSP-related clinical signs or symptoms.
|
Symptomatic/Definitive ALSP (no HSCT)
n=14 Participants
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and did not have hematopoietic stem cell transplant (HSCT) procedure.
|
Symptomatic/Definitive ALSP (Prior HSCT)
n=10 Participants
ALSP participants with CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and had prior hematopoietic stem cell transplant (HSCT) procedure.
|
|---|---|---|---|
|
Magnetic Resonance Imaging (MRI) Ventricle Volume
|
498.3 cubic millimeter
Standard Deviation 833.03
|
4153.2 cubic millimeter
Standard Deviation 6052.35
|
3061.5 cubic millimeter
Standard Deviation 5142.76
|
PRIMARY outcome
Timeframe: Month 12Population: Not all participants completed Month 12 visit prior to data cutoff.
Change from Baseline in ventricle volume at Month 12
Outcome measures
| Measure |
Prodromal
n=18 Participants
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP, and who had none or up to and including 2 ALSP-related clinical signs or symptoms.
|
Symptomatic/Definitive ALSP (no HSCT)
n=7 Participants
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and did not have hematopoietic stem cell transplant (HSCT) procedure.
|
Symptomatic/Definitive ALSP (Prior HSCT)
n=9 Participants
ALSP participants with CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and had prior hematopoietic stem cell transplant (HSCT) procedure.
|
|---|---|---|---|
|
Magnetic Resonance Imaging (MRI) Ventricle Volume
|
1030.5 cubic millimeter
Standard Deviation 1409.76
|
10410.0 cubic millimeter
Standard Deviation 7798.42
|
3565.6 cubic millimeter
Standard Deviation 8930.46
|
PRIMARY outcome
Timeframe: Month 18Population: Not all participants completed Month 18 visit prior to data cutoff.
Change from Baseline in ventricle volume at Month 18
Outcome measures
| Measure |
Prodromal
n=17 Participants
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP, and who had none or up to and including 2 ALSP-related clinical signs or symptoms.
|
Symptomatic/Definitive ALSP (no HSCT)
n=2 Participants
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and did not have hematopoietic stem cell transplant (HSCT) procedure.
|
Symptomatic/Definitive ALSP (Prior HSCT)
n=8 Participants
ALSP participants with CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and had prior hematopoietic stem cell transplant (HSCT) procedure.
|
|---|---|---|---|
|
Magnetic Resonance Imaging (MRI) Ventricle Volume
|
1236.9 cubic millimeter
Standard Deviation 2139.02
|
17758.8 cubic millimeter
Standard Deviation 17376.19
|
5462.0 cubic millimeter
Standard Deviation 6719.45
|
PRIMARY outcome
Timeframe: Month 24Population: Not all participants completed Month 24 visit prior to data cutoff.
Change from Baseline in ventricle volume at Month 24
Outcome measures
| Measure |
Prodromal
n=11 Participants
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP, and who had none or up to and including 2 ALSP-related clinical signs or symptoms.
|
Symptomatic/Definitive ALSP (no HSCT)
n=1 Participants
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and did not have hematopoietic stem cell transplant (HSCT) procedure.
|
Symptomatic/Definitive ALSP (Prior HSCT)
n=9 Participants
ALSP participants with CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and had prior hematopoietic stem cell transplant (HSCT) procedure.
|
|---|---|---|---|
|
Magnetic Resonance Imaging (MRI) Ventricle Volume
|
1216.8 cubic millimeter
Standard Deviation 2013.70
|
8901.6 cubic millimeter
Standard Deviation NA
only 1 value
|
5406.7 cubic millimeter
Standard Deviation 5977.76
|
PRIMARY outcome
Timeframe: Month 30Population: Not all participants completed Month 30 visit prior to data cutoff.
Change from Baseline in ventricle volume at Month 30
Outcome measures
| Measure |
Prodromal
n=6 Participants
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP, and who had none or up to and including 2 ALSP-related clinical signs or symptoms.
|
Symptomatic/Definitive ALSP (no HSCT)
n=1 Participants
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and did not have hematopoietic stem cell transplant (HSCT) procedure.
|
Symptomatic/Definitive ALSP (Prior HSCT)
n=4 Participants
ALSP participants with CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and had prior hematopoietic stem cell transplant (HSCT) procedure.
|
|---|---|---|---|
|
Magnetic Resonance Imaging (MRI) Ventricle Volume
|
1837.6 cubic millimeter
Standard Deviation 2931.17
|
13821.3 cubic millimeter
Standard Deviation NA
only 1 value
|
9115.2 cubic millimeter
Standard Deviation 8421.27
|
Adverse Events
Prodromal
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Symptomatic/Definitive ALSP (no HSCT)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Symptomatic/Definitive ALSP (Prior HSCT)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prodromal
n=19 participants at risk
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP, and who had none or up to and including 2 ALSP-related clinical signs or symptoms.
|
Symptomatic/Definitive ALSP (no HSCT)
n=23 participants at risk
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and did not have hematopoietic stem cell transplant (HSCT) procedure.
|
Symptomatic/Definitive ALSP (Prior HSCT)
n=11 participants at risk
ALSP participants with CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and had prior hematopoietic stem cell transplant (HSCT) procedure.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
4.3%
1/23 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
4.3%
1/23 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
4.3%
1/23 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
9.1%
1/11 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
Other adverse events
| Measure |
Prodromal
n=19 participants at risk
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP, and who had none or up to and including 2 ALSP-related clinical signs or symptoms.
|
Symptomatic/Definitive ALSP (no HSCT)
n=23 participants at risk
ALSP participants with confirmed CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and did not have hematopoietic stem cell transplant (HSCT) procedure.
|
Symptomatic/Definitive ALSP (Prior HSCT)
n=11 participants at risk
ALSP participants with CSF1R mutation, radiographic evidence of ALSP and had at least 3 ALSP-related clinical signs or symptoms, and had prior hematopoietic stem cell transplant (HSCT) procedure.
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
5.3%
1/19 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.3%
1/19 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Gastrointestinal disorders
Gastric ulcer
|
5.3%
1/19 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Nervous system disorders
Bronchitis
|
5.3%
1/19 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Infections and infestations
COVID-19
|
5.3%
1/19 • Number of events 2 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Eye disorders
Glaucoma
|
5.3%
1/19 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
4.3%
1/23 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
4.3%
1/23 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
4.3%
1/23 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
4.3%
1/23 • Number of events 4 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Musculoskeletal and connective tissue disorders
Facial asymmetry
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
4.3%
1/23 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
4.3%
1/23 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
4.3%
1/23 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
4.3%
1/23 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Nervous system disorders
Migraine without aura
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
4.3%
1/23 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
9.1%
1/11 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
9.1%
1/11 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Infections and infestations
Infection
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
9.1%
1/11 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Psychiatric disorders
Depression
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
9.1%
1/11 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
9.1%
1/11 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Infections and infestations
Uriinary tract infection
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
9.1%
1/11 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
9.1%
1/11 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/19 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
9.1%
1/11 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • Number of events 1 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/23 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
0.00%
0/11 • From the time of signing the informed consent through up to 36 months
For this observational study, an adverse event was defind as any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to a study procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place