Trial Outcomes & Findings for A Study to Evaluate Administration of SBT101 Gene Therapy in Adult Patients With Adrenomyeloneuropathy (AMN) (NCT NCT05394064)
NCT ID: NCT05394064
Last Updated: 2026-08-26
Results Overview
Any Treatment Emergent Adverse Event (TEAE). TEAE was defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
2 years
Results posted on
2026-08-26
Participant Flow
Participant milestones
| Measure |
Dose Level 1
Patients treated with SBT101 (1.0E14 vector genomes) in Dose Escalation Phase
|
Dose Level 2
Patients treated with SBT101 (3.0E14 vector genomes) in Dose Escalation Phase
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
Enrolled at study closure
|
3
|
5
|
|
Overall Study
COMPLETED
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 1
Patients treated with SBT101 (1.0E14 vector genomes) in Dose Escalation Phase
|
Dose Level 2
Patients treated with SBT101 (3.0E14 vector genomes) in Dose Escalation Phase
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate Administration of SBT101 Gene Therapy in Adult Patients With Adrenomyeloneuropathy (AMN)
Baseline characteristics by cohort
| Measure |
Cohort 1 - Dose Level 1
n=4 Participants
Patients treated with SBT101 (1.0E14 vector genomes) in Dose Escalation Phase. Safety analysis set (all participants who received any amount of SBT101 as part of the study).
|
Cohort 2 - Dose Level 2
n=4 Participants
Patients treated with SBT101 (3.0E14 vector genomes) in Dose Escalation Phase. Safety analysis set (all participants who received any amount of SBT101 as part of the study).
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.3 Years
STANDARD_DEVIATION 7.41 • n=31 Participants
|
35 Years
STANDARD_DEVIATION 1.41 • n=49 Participants
|
31.6 Years
STANDARD_DEVIATION 6.12 • n=80 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=31 Participants
|
4 Participants
n=49 Participants
|
8 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=31 Participants
|
4 Participants
n=49 Participants
|
7 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=31 Participants
|
4 Participants
n=49 Participants
|
8 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Confirmed Mutation in the ABCD1 Gene
|
4 Participants
n=31 Participants
|
4 Participants
n=49 Participants
|
8 Participants
n=80 Participants
|
|
Adrenal Insufficiency
Yes
|
3 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
5 Participants
n=80 Participants
|
|
Adrenal Insufficiency
No
|
1 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
|
Time Since AMN Diagnosis
|
2.41 Years
STANDARD_DEVIATION 1.720 • n=31 Participants
|
1.74 Years
STANDARD_DEVIATION 0.811 • n=49 Participants
|
2.14 Years
STANDARD_DEVIATION 1.333 • n=80 Participants
|
|
Baseline EDSS
|
3.25 Score on a scale
STANDARD_DEVIATION 0.645 • n=31 Participants
|
2.88 Score on a scale
STANDARD_DEVIATION 0.854 • n=49 Participants
|
3.06 Score on a scale
STANDARD_DEVIATION 0.729 • n=80 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Safety Analysis Set (all participants who received any amount of SBT101 as part of the study).
Any Treatment Emergent Adverse Event (TEAE). TEAE was defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication.
Outcome measures
| Measure |
Cohort 1 - Dose Level 1
n=4 Participants
Patients treated with SBT101 (1.0E14 vector genomes). Safety analysis set (all participants who received any amount of SBT101 as part of the study).
|
Cohort 2 - Dose Level 2
n=4 Participants
Patients treated with SBT101 (3.0E14 vector genomes). Safety analysis set (all participants who received any amount of SBT101 as part of the study).
|
|---|---|---|
|
Adverse Events to SBT101. Any Serious TEAE. Any Serious TEAE Related to the Study Procedure or Study Drug.
Any TEAE
|
4 Participants
|
4 Participants
|
|
Adverse Events to SBT101. Any Serious TEAE. Any Serious TEAE Related to the Study Procedure or Study Drug.
Any Grade 3 or 4 TEAE related to study procedure or study drug
|
2 Participants
|
0 Participants
|
Adverse Events
Cohort 1 - Dose Level 1
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Cohort 2 - Dose Level 2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - Dose Level 1
n=4 participants at risk
Patients treated with SBT101 (1.0E14 vector genomes). Safety analysis set (all participants who received any amount of SBT101 as part of the study).
|
Cohort 2 - Dose Level 2
n=4 participants at risk
Patients treated with SBT101 (3.0E14 vector genomes). Safety analysis set (all participants who received any amount of SBT101 as part of the study).
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Infections and infestations
Pyelonephritis
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Myelitis transverse
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
Other adverse events
| Measure |
Cohort 1 - Dose Level 1
n=4 participants at risk
Patients treated with SBT101 (1.0E14 vector genomes). Safety analysis set (all participants who received any amount of SBT101 as part of the study).
|
Cohort 2 - Dose Level 2
n=4 participants at risk
Patients treated with SBT101 (3.0E14 vector genomes). Safety analysis set (all participants who received any amount of SBT101 as part of the study).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
75.0%
3/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Musculoskeletal and connective tissue disorders
Nervous system disorders
|
100.0%
4/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
100.0%
4/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Headache
|
75.0%
3/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
100.0%
4/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
100.0%
4/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Hypoaesthesia
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Balance disorder
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Clonus
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Fine motor skill dysfunction
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Hypotonia
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Muscle spasticity
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Nervous system disorders
Taste disorder
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Infections and infestations
Influenza
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Infections and infestations
Cellulitis
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Infections and infestations
Gastroenteritis viral
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Infections and infestations
Pharyrngitis streptococcal
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Infections and infestations
Wound infection staphylococcal
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Psychiatric disorders
Insomnia
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Psychiatric disorders
Emotional disorder
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Psychiatric disorders
Euphoric mood
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Psychiatric disorders
Poor quality sleep
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Psychiatric disorders
Abnormal dreams
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Psychiatric disorders
Affect lability
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Psychiatric disorders
Depressed mood
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Psychiatric disorders
Hypomania
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Psychiatric disorders
Tension
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Renal and urinary disorders
Micturition urgency
|
75.0%
3/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Renal and urinary disorders
Pollakiuria
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Renal and urinary disorders
Dysuria
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
General disorders
Fatigue
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
75.0%
3/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
General disorders
Asthenia
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
General disorders
Gait disturbance
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
General disorders
Thirst
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
General disorders
Impaired healing
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Skin and subcutaneous tissue disorders
Acne
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Anal incontinence
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Food poisoning
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Injury, poisoning and procedural complications
Fall
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Injury, poisoning and procedural complications
Abdominal wall wound
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Injury, poisoning and procedural complications
Limb injury
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Injury, poisoning and procedural complications
Wound
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Endocrine disorders
Cushingoid
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Endocrine disorders
Steroid withdrawal syndrome
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Immune system disorders
Immune-mediated adverse reaction
|
50.0%
2/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Investigations
Weight increased
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Investigations
Blood creatine phosphokinase increased
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Investigations
Blood follicle stimulating hormone increased
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Investigations
Blood glucose increased
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Investigations
Heart rate increased
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Investigations
Urine output decreased
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Ear and labyrinth disorders
Tinnitus
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Eye disorders
Lacrimation increased
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Eye disorders
Visual impairment
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Metabolism and nutrition disorders
Increased appetite
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
|
Congenital, familial and genetic disorders
Adrenoleukodystrophy
|
0.00%
0/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
25.0%
1/4 • From enrollment until 30 days after the patient's last visit (up to 24 months).
Treatment-emergent adverse events (TEAEs) were defined as any adverse event which started during or after the administration of IMP or the immunosuppressant pre-medication. Only TEAEs are reported.
|
Additional Information
Spur Clinical Trials Contact
Spur Therapeutics Limited
Phone: +441438906870
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place