Trial Outcomes & Findings for HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients (NCT NCT03569891)
NCT ID: NCT03569891
Last Updated: 2026-03-27
Results Overview
Adjusted ABR for Lead-in and Post-Treatment period was estimated from a repeated measures generalized estimating equations negative binomial regression model accounting for the paired design of the trial with an offset parameter to account for the differential collection periods. Treatment period was included as a categorical covariate.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
67 participants
Primary outcome timeframe
Lead-in period and months 7-18 post-treatment of AMT-061 (CSL222)
Results posted on
2026-03-27
Participant Flow
This study was conducted at 33 sites, 17 in the United States, 13 in the European Union, and 3 in the United Kingdom.
A total of 75 participants were screened for the study. Of these, 67 entered the Lead-in Period, while 8 were screening failures.
Participant milestones
| Measure |
All Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), participants received their usual standard of care, continuous coagulation factor IX (FIX) prophylaxis. They recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary. Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|
|
Period 1: Lead-in
STARTED
|
67
|
|
Period 1: Lead-in
COMPLETED
|
54
|
|
Period 1: Lead-in
NOT COMPLETED
|
13
|
|
Period 2: AMT-061 (CSL222)
STARTED
|
54
|
|
Period 2: AMT-061 (CSL222)
COMPLETED
|
53
|
|
Period 2: AMT-061 (CSL222)
NOT COMPLETED
|
1
|
|
Period 3: Long-term Follow up
STARTED
|
54
|
|
Period 3: Long-term Follow up
COMPLETED
|
50
|
|
Period 3: Long-term Follow up
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
All Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), participants received their usual standard of care, continuous coagulation factor IX (FIX) prophylaxis. They recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary. Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|
|
Period 1: Lead-in
Ineligible during lead-in
|
8
|
|
Period 1: Lead-in
Risks related to COVID-19
|
2
|
|
Period 1: Lead-in
Withdrawal by Subject
|
3
|
|
Period 2: AMT-061 (CSL222)
Adverse Event
|
1
|
|
Period 3: Long-term Follow up
TEAE With a Fatal Outcome
|
2
|
|
Period 3: Long-term Follow up
Subject Withdrew Consent
|
1
|
|
Period 3: Long-term Follow up
Participant missed end-of-study efficacy assessment
|
1
|
Baseline Characteristics
HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients
Baseline characteristics by cohort
| Measure |
All Participants
n=67 Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), participants received their usual standard of care, continuous coagulation factor IX (FIX) prophylaxis. They recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary. Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=56 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=56 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=56 Participants
|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 16.2 • n=56 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=56 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=56 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=56 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=56 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=56 Participants
|
|
Region of Enrollment
Sweden
|
2 participants
n=56 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=56 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=56 Participants
|
|
Region of Enrollment
Ireland
|
3 participants
n=56 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=56 Participants
|
|
Region of Enrollment
Italy
|
5 participants
n=56 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=56 Participants
|
|
Region of Enrollment
Denmark
|
3 participants
n=56 Participants
|
PRIMARY outcome
Timeframe: Lead-in period and months 7-18 post-treatment of AMT-061 (CSL222)Population: Full Analysis Set (FAS) included all participants who were enrolled, entered the lead-in phase, were dosed with AMT-061 (CSL222), and provided at least 1 efficacy endpoint assessment for any efficacy endpoint subsequent to AMT-061 (CSL222) dosing. Participants who were Lead-in Discontinuers were not included in the FAS.
Adjusted ABR for Lead-in and Post-Treatment period was estimated from a repeated measures generalized estimating equations negative binomial regression model accounting for the paired design of the trial with an offset parameter to account for the differential collection periods. Treatment period was included as a categorical covariate.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Annualized Bleeding Rate (ABR) for All Bleeding Episodes
|
4.19 bleeds/year/participants
Interval 3.22 to 5.45
|
1.51 bleeds/year/participants
Interval 0.81 to 2.82
|
SECONDARY outcome
Timeframe: At Baseline, 6, 12, and 18 months after AMT-061 (CSL222) dosingPopulation: FAS. Here, 'number analyzed' = participants with available data at each specified timepoint.
One-stage activated partial thromboplastin time (aPTT) based endogenous FIX activity levels from central laboratory assay.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Factor IX Activity Levels After AMT-061 (CSL222) Dosing
Baseline
|
1.19 Factor IX activity (%)
Standard Deviation 0.39
|
—
|
|
Factor IX Activity Levels After AMT-061 (CSL222) Dosing
6 months
|
38.95 Factor IX activity (%)
Standard Deviation 18.72
|
—
|
|
Factor IX Activity Levels After AMT-061 (CSL222) Dosing
12 months
|
41.48 Factor IX activity (%)
Standard Deviation 21.71
|
—
|
|
Factor IX Activity Levels After AMT-061 (CSL222) Dosing
18 months
|
36.90 Factor IX activity (%)
Standard Deviation 21.40
|
—
|
SECONDARY outcome
Timeframe: Lead-in period and months 0-6, 7-12, and 13-18 after AMT-061 (CSL222) dosingPopulation: FAS. Here, 'number analyzed' = participants with available data at each specified timepoint.
Annualized consumption of FIX replacement therapy.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Annualized Exogenous FIX Consumption
Lead-in
|
257,338.8 International Units (IU)/year
Standard Deviation 149,013.1
|
—
|
|
Annualized Exogenous FIX Consumption
Months 0-6
|
—
|
12,912.9 International Units (IU)/year
Standard Deviation 37,093.1
|
|
Annualized Exogenous FIX Consumption
Months 7-12
|
—
|
8399.1 International Units (IU)/year
Standard Deviation 29,720.9
|
|
Annualized Exogenous FIX Consumption
Months 13-18
|
—
|
8486.6 International Units (IU)/year
Standard Deviation 28,770.2
|
SECONDARY outcome
Timeframe: Lead-in period and months 7-18 after AMT-061 (CSL222) dosingPopulation: FAS. Here, 'number analyzed' = participants with available data at each specified timepoint.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Adjusted Annualized Infusion Rate of FIX Replacement Therapy
Lead-in
|
72.49 Infusions/year
Interval 63.52 to 82.71
|
—
|
|
Adjusted Annualized Infusion Rate of FIX Replacement Therapy
Months 7-18
|
—
|
2.53 Infusions/year
Interval 0.92 to 6.96
|
SECONDARY outcome
Timeframe: Months 7-18 after AMT-061 (CSL222) dosingPopulation: FAS.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Percent of Participants Who Discontinued FIX Prophylaxis and Remained Free of Routine FIX Prophylaxis After AMT-061 (CSL222) Dosing
|
96.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Lead-in and 3, 12, and 18 months after AMT-061 (CSL222) dosingPopulation: FAS. Here, 'number analyzed' = participants with available data at each specified timepoint.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Percentage of Participants With Trough FIX Activity <12% of Normal
Lead-in
|
79.6 percentage of participants
|
—
|
|
Percentage of Participants With Trough FIX Activity <12% of Normal
12 months
|
—
|
8.0 percentage of participants
|
|
Percentage of Participants With Trough FIX Activity <12% of Normal
18 months
|
—
|
6.0 percentage of participants
|
|
Percentage of Participants With Trough FIX Activity <12% of Normal
3 months
|
—
|
7.8 percentage of participants
|
SECONDARY outcome
Timeframe: Lead-in and Months 7-18 after AMT-061 (CSL222) dosingPopulation: FAS.
Adjusted ABR for Lead-In and Post-Treatment period was estimated from a repeated measures generalized estimating equations negative binomial regression model accounting for the paired design of the trial with an offset parameter to account for the differential collection periods. Treatment period was included as a categorical covariate.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
ABR for FIX-treated Bleeding Episodes
|
3.65 bleeds/year/participant
Interval 2.82 to 4.74
|
0.84 bleeds/year/participant
Interval 0.41 to 1.73
|
SECONDARY outcome
Timeframe: Lead-in period and months 7-18 after AMT-061 (CSL222) dosingPopulation: FAS. Here, 'number analyzed' = participants with available data at each specified timepoint.
Adjusted ABR for Lead-In and Post-Treatment period was estimated from a repeated measures generalized estimating equations negative binomial regression model accounting for the paired design of the trial with an offset parameter to account for the differential collection periods. Treatment period was included as a categorical covariate.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Annualized Rate of Spontaneous Bleeding Episodes
Lead-in
|
1.52 bleeds/year/participant
Interval 1.01 to 2.3
|
—
|
|
Annualized Rate of Spontaneous Bleeding Episodes
Months 7-18
|
—
|
0.44 bleeds/year/participant
Interval 0.17 to 1.12
|
SECONDARY outcome
Timeframe: Lead-in period and months 7-18 after AMT-061 (CSL222) dosingPopulation: FAS. Here, 'number analyzed' = participants with available data at each specified timepoint.
Adjusted ABR for Lead-In and Post-Treatment period was estimated from a repeated measures generalized estimating equations negative binomial regression model accounting for the paired design of the trial with an offset parameter to account for the differential collection periods. Treatment period was included as a categorical covariate.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Annualized Rate of Joint Bleeding Episodes
Lead-in
|
2.35 bleeds/year/participant
Interval 1.74 to 3.16
|
—
|
|
Annualized Rate of Joint Bleeding Episodes
Months 7-18
|
—
|
0.51 bleeds/year/participant
Interval 0.23 to 1.12
|
SECONDARY outcome
Timeframe: At Baseline, 6, 12, and 18 months after AMT-061 (CSL222) dosingPopulation: FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data at each specified timepoint.
One-stage aPTT-based endogenous FIX activity levels from central laboratory assay.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=21 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Mean FIX Activity (%) in Participants With Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 (CSL222) Dosing
Baseline
|
1.24 Factor IX activity (%)
Standard Deviation 0.44
|
—
|
|
Mean FIX Activity (%) in Participants With Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 (CSL222) Dosing
6 months
|
35.91 Factor IX activity (%)
Standard Deviation 19.02
|
—
|
|
Mean FIX Activity (%) in Participants With Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 (CSL222) Dosing
12 months
|
35.54 Factor IX activity (%)
Standard Deviation 17.84
|
—
|
|
Mean FIX Activity (%) in Participants With Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 (CSL222) Dosing
18 months
|
31.14 Factor IX activity (%)
Standard Deviation 13.75
|
—
|
SECONDARY outcome
Timeframe: At Baseline, 6, 12 and 18 months after AMT-061 (CSL222) dosingPopulation: FAS. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data at each specified timepoint.
One-stage aPTT-based endogenous FIX activity levels from central laboratory assay.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=33 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Mean FIX Activity (%) in Participants Without Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 (CSL222) Dosing
Baseline
|
1.15 Factor IX activity (%)
Standard Deviation 0.36
|
—
|
|
Mean FIX Activity (%) in Participants Without Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 (CSL222) Dosing
6 months
|
40.61 Factor IX activity (%)
Standard Deviation 18.64
|
—
|
|
Mean FIX Activity (%) in Participants Without Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 (CSL222) Dosing
12 months
|
44.82 Factor IX activity (%)
Standard Deviation 23.21
|
—
|
|
Mean FIX Activity (%) in Participants Without Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 (CSL222) Dosing
18 months
|
39.87 Factor IX activity (%)
Standard Deviation 24.08
|
—
|
SECONDARY outcome
Timeframe: Up to 18 months after AMT-061 (CSL222) dosingPopulation: FAS.
A target joint was defined as 3 or more spontaneous bleeding episodes into a single joint within a consecutive 6-month period prior to the dosing visit and which was not resolved by the time of dosing. An identified target joint with ≤2 spontaneous bleeding episodes within a consecutive 12-month period was considered resolved.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Number of New Target Joints and the Number of New Target Joints Resolved
New target joints
|
1 Joints
|
—
|
|
Number of New Target Joints and the Number of New Target Joints Resolved
New target joints resolved
|
0 Joints
|
—
|
SECONDARY outcome
Timeframe: Lead-in period and months 7-18 post-treatment of AMT-061 (CSL222)Population: FAS.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Percent of Participants With Zero Bleeding Episodes During the 52 Weeks Following Stable FIX Expression (6 to 18 Months) After AMT-061 (CSL222) Dosing
|
25.9 percentage of participants
|
63.0 percentage of participants
|
SECONDARY outcome
Timeframe: Lead-in period and up to 12 months after AMT-061 (CSL222) dosingPopulation: FAS.
The iPAQ was designed to provide an evaluation of daily physical activities in metabolic equivalent of task (MET) minutes/week. To calculate MET minutes a week multiply the MET value given (walking = 3.3, moderate activity = 4, vigorous activity = 8) by the minutes the activity was carried out and again by the number of days the activity was undertaken. A higher score is considered to be more favorable.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
International Physical Activity Questionnaire (iPAQ) Overall Score
|
4548.1 MET minutes/week
Standard Error 512.38
|
3826.9 MET minutes/week
Standard Error 480.44
|
SECONDARY outcome
Timeframe: Lead-in period and up to 12 months after AMT-061 (CSL222) dosingPopulation: FAS.
The EQ-5D-5L descriptive system of health-related QoL states consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The EQ-5D-5L VAS overall score ranges from 0 to 100. A higher score is considered to be more favorable.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) VAS Overall Score
|
80.9 score on a scale
Standard Error 2.20
|
81.0 score on a scale
Standard Error 2.15
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Analysis was performed on Post-treatment safety population which consisted of all participants who received AMT-061 (CSL222) irrespective of any protocol deviations.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
54 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Analysis was performed on Post-treatment safety population which consisted of all participants who received AMT-061 (CSL222) irrespective of any protocol deviations. Here, 'number analyzed' = participants with available data at each specified category.
To monitor participants for liver fibrosis and potential occurrences of liver malignancies, abdominal ultrasounds were performed. Number of participants with change in abdominal ultrasound result from normal to abnormal, abnormal to abnormal (no change) and missing to abnormal are reported for this outcome measure.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Number of Participants With Change (Shift) in Abdominal Ultrasound Results From Normal, Abnormal and Missing to Abnormal Post Treatment
Normal to Abnormal
|
21 Participants
|
—
|
|
Number of Participants With Change (Shift) in Abdominal Ultrasound Results From Normal, Abnormal and Missing to Abnormal Post Treatment
Abnormal to Abnormal
|
22 Participants
|
—
|
|
Number of Participants With Change (Shift) in Abdominal Ultrasound Results From Normal, Abnormal and Missing to Abnormal Post Treatment
Missing to Abnormal
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: At Month 60Population: Analysis was performed on Post-treatment safety population which consisted of all participants who received AMT-061 (CSL222) irrespective of any protocol deviations. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and "number analyzed" = participants with available data for each specified category.
Number of participants who developed antibodies directed against AAV5 (including IgM, IgG and neutralizing antibodies) are reported for this outcome measure. A participant was reported as having an IgG and IgM anti-AAV5 antibody titer greater than or equal to (≥) the LOD if both the screening and confirmatory test results were positive and the titer value was ≥ 50.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=50 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Number of Participants With Anti-AAV5 Antibodies
Anti-AAV5 IgG Antibodies
|
49 Participants
|
—
|
|
Number of Participants With Anti-AAV5 Antibodies
Anti-AAV5 IgM Antibodies
|
8 Participants
|
—
|
|
Number of Participants With Anti-AAV5 Antibodies
Neutralizing Antibodies
|
50 Participants
|
—
|
SECONDARY outcome
Timeframe: At Month 12 after treatmentPopulation: Analysis was performed on Post-treatment safety population, which consisted of all participants who received AMT-061 (CSL222) irrespective of any protocol deviations. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=40 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Number of Participants With AAV5 Capsid-specific T Cells
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: At Month 60Population: Analysis was performed on Post-treatment safety population which consisted of all participants who received AMT-061 (CSL222) irrespective of any protocol deviations. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=49 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Number of Participants With Anti-FIX Antibodies
Negative
|
48 Participants
|
—
|
|
Number of Participants With Anti-FIX Antibodies
Positive
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Month 60Population: Analysis was performed on Post-treatment safety population which consisted of all participants who received AMT-061 (CSL222) irrespective of any protocol deviations. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Number of participants with \>LOD level of fix inhibitors up to Month 60 are reported for this outcome measure. Here, LOD = 0.415 Nijmegen-Bethesda Units per milliliter (NBU/mL).
Outcome measures
| Measure |
AMT-061 (CSL222)
n=49 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Number of Participants With FIX Inhibitors and Recovery
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Month 60Population: Analysis was performed on Post-treatment safety population which consisted of all participants who received AMT-061 (CSL222) irrespective of any protocol deviations.
Number of participants with increased AST and ALT levels and who used corticosteroids to treat these elevations are reported for this outcome measure.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Number of Participants With Increased Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels And Who Used Any Corticosteroids For Treatments
ALT increase
|
13 Participants
|
—
|
|
Number of Participants With Increased Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels And Who Used Any Corticosteroids For Treatments
AST increase
|
10 Participants
|
—
|
|
Number of Participants With Increased Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels And Who Used Any Corticosteroids For Treatments
Use of Corticosteroids
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Month 60Population: Analysis was performed on Post-treatment safety population which consisted of all participants who received AMT-061 (CSL222) irrespective of any protocol deviations.
Only parameters with post-baseline, newly occurring or worsening potentially clinically significant laboratory values are reported for this outcome measure. Criteria threshold: Hemoglobin: \< 80 grams per liter (g/L); Platelet Count: \< 50 10\^9 cells per liter; AST and ALT: \> 2 x Baseline value; Total Bilirubin: \> 2 x upper limit of normal (ULN).
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Number of Participants With Newly Occurring or Worsening Potentially Clinically Significant Laboratory Values
Hemoglobin
|
1 Participants
|
—
|
|
Number of Participants With Newly Occurring or Worsening Potentially Clinically Significant Laboratory Values
Platelet Count
|
1 Participants
|
—
|
|
Number of Participants With Newly Occurring or Worsening Potentially Clinically Significant Laboratory Values
AST
|
11 Participants
|
—
|
|
Number of Participants With Newly Occurring or Worsening Potentially Clinically Significant Laboratory Values
ALT
|
19 Participants
|
—
|
|
Number of Participants With Newly Occurring or Worsening Potentially Clinically Significant Laboratory Values
Total Bilirubin
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 12 months after treatmentPopulation: Analysis was performed on Post-treatment safety population, which consisted of all participants who received AMT-061 (CSL222) irrespective of any protocol deviations.
A participant was considered to no longer be shedding vector DNA if they had a negative laboratory result (\<LOD) for 3 or more consecutive timepoints.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=54 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Number of Participants With Vector DNA Shedding
Semen
|
45 Participants
|
—
|
|
Number of Participants With Vector DNA Shedding
Blood
|
49 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 12 months after treatmentPopulation: Analysis was performed on Post-treatment safety population, which consisted of all participants who received AMT-061 (CSL222) irrespective of any protocol deviations. Here, "overall number of participants analyzed" = participants with available data for this outcome measure.
Inflammatory markers assessed included Interleukin-1beta (IL-1β), Interleukin-2 (IL-2), Interleukin-6 (IL-6), Interferon gamma (IFNγ), and Monocyte chemotactic protein-1 (MCP-1). Lower limit of quantification (LLOQ): IFNγ = 2.86 nanograms per milliliter (ng/mL), IL-1β = 0.60 ng/mL, IL-2 = 0.72 ng/mL, IL-6 = 0.94 ng/mL, MCP-1 = 1.68 ng/mL. Number of participants with inflammatory markers \>= LLOQ are reported for this outcome measure.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=53 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Number of Participants With Inflammatory Markers
IFNγ
|
45 Participants
|
—
|
|
Number of Participants With Inflammatory Markers
IL-1β
|
1 Participants
|
—
|
|
Number of Participants With Inflammatory Markers
IL-2
|
0 Participants
|
—
|
|
Number of Participants With Inflammatory Markers
IL-6
|
17 Participants
|
—
|
|
Number of Participants With Inflammatory Markers
MCP-1
|
53 Participants
|
—
|
SECONDARY outcome
Timeframe: At Month 60Population: Analysis was performed on Post-treatment safety population which consisted of all participants who received AMT-061 (CSL222) irrespective of any protocol deviations. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Number of participants with AFP levels \>= LLOQ at Month 60 are reported for this outcome measure. LLOQ for AFP = 1.09 IU/mL.
Outcome measures
| Measure |
AMT-061 (CSL222)
n=50 Participants
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
AMT-061 (CSL222)
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|
|
Number of Participants With Alpha-fetoprotein (AFP) Levels Above LLOQ at Month 60
|
43 Participants
|
—
|
Adverse Events
Lead-In (Including Discontinuers)
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Lead-In (Not Including Discontinuers)
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
AMT-061 (CSL222)
Serious events: 20 serious events
Other events: 53 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Lead-In (Including Discontinuers)
n=67 participants at risk
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), participants received their usual standard of care, continuous FIX prophylaxis. They recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary. Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period.
|
Lead-In (Not Including Discontinuers)
n=54 participants at risk
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), participants received their usual standard of care, continuous FIX prophylaxis. They recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary. Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period.
|
AMT-061 (CSL222)
n=54 participants at risk
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Haemophilic arthropathy
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
COVID-19
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
General disorders
Complication Associated With Device
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
Biloma infected
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
Device related infection
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
3.7%
2/54 • Number of events 2 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 2 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Product Issues
Device breakage
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Psychiatric disorders
Depression
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
Other adverse events
| Measure |
Lead-In (Including Discontinuers)
n=67 participants at risk
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), participants received their usual standard of care, continuous FIX prophylaxis. They recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary. Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period.
|
Lead-In (Not Including Discontinuers)
n=54 participants at risk
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), participants received their usual standard of care, continuous FIX prophylaxis. They recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary. Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period.
|
AMT-061 (CSL222)
n=54 participants at risk
Participants received a single infusion of AAV5-hFIXco-Padua at baseline after the lead-in period. Participants who received treatment with AMT-061 (CSL222) were followed for 5 years post-treatment.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
5/67 • Number of events 5 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
7.4%
4/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
46.3%
25/54 • Number of events 54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
29.6%
16/54 • Number of events 20 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
18.5%
10/54 • Number of events 11 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
9.3%
5/54 • Number of events 5 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
9.3%
5/54 • Number of events 6 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
General disorders
Fatigue
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
29.6%
16/54 • Number of events 20 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
General disorders
Influenza like illness
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
14.8%
8/54 • Number of events 15 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
General disorders
Pain
|
3.0%
2/67 • Number of events 2 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
9.3%
5/54 • Number of events 5 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
General disorders
Malaise
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
9.3%
5/54 • Number of events 7 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
General disorders
Chest pain
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
11.1%
6/54 • Number of events 6 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
General disorders
Chills
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
7.4%
4/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
General disorders
Pyrexia
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
7.4%
4/54 • Number of events 5 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
Nasopharyngitis
|
11.9%
8/67 • Number of events 8 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
14.8%
8/54 • Number of events 8 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
33.3%
18/54 • Number of events 26 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
Cystitis
|
3.0%
2/67 • Number of events 2 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
3.7%
2/54 • Number of events 2 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
COVID-19
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
33.3%
18/54 • Number of events 20 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
Influenza
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
13.0%
7/54 • Number of events 10 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Gastrointestinal disorders
Nausea
|
3.0%
2/67 • Number of events 2 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
3.7%
2/54 • Number of events 2 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
13.0%
7/54 • Number of events 8 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
13.0%
7/54 • Number of events 7 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Gastrointestinal disorders
Toothache
|
3.0%
2/67 • Number of events 2 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
3.7%
2/54 • Number of events 2 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
14.8%
8/54 • Number of events 13 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
11.1%
6/54 • Number of events 7 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Nervous system disorders
Headache
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
35.2%
19/54 • Number of events 35 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
14.8%
8/54 • Number of events 8 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
24.1%
13/54 • Number of events 14 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
18.5%
10/54 • Number of events 14 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
18.5%
10/54 • Number of events 12 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Investigations
C-reactive protein increased
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
11.1%
6/54 • Number of events 6 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.5%
3/67 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
3.7%
2/54 • Number of events 2 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
14.8%
8/54 • Number of events 8 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
18.5%
10/54 • Number of events 10 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
7.4%
4/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
2/67 • Number of events 2 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
9.3%
5/54 • Number of events 5 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
3.0%
2/67 • Number of events 2 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
3.7%
2/54 • Number of events 2 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
7.4%
4/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
13.0%
7/54 • Number of events 7 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
9.3%
5/54 • Number of events 6 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Vascular disorders
Hypertension
|
1.5%
1/67 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
1.9%
1/54 • Number of events 1 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
14.8%
8/54 • Number of events 8 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
11.1%
6/54 • Number of events 6 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
7.4%
4/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
7.4%
4/54 • Number of events 5 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
9.3%
5/54 • Number of events 7 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
7.4%
4/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
7.4%
4/54 • Number of events 5 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Investigations
Blood glucose increased
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
9.3%
5/54 • Number of events 5 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
7.4%
4/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
9.3%
5/54 • Number of events 5 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 8 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
20.4%
11/54 • Number of events 11 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
7.4%
4/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Psychiatric disorders
Depression
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
7.4%
4/54 • Number of events 4 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 5 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
5.6%
3/54 • Number of events 3 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/67 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
0.00%
0/54 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
7.4%
4/54 • Number of events 7 • From the signing of informed consent form up to 5 years after treatment
The Safety Population consisted of all participants who were enrolled in either the Lead-in Safety Population (ie, all participants who were enrolled into the lead-in period) or the Post-treatment Safety Population (ie, all participants who received AMT-061 \[CSL222\], irrespective of any protocol deviations, in the post-treatment period).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place