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: 2025-05-04
Results Overview
ABR was calculated as the ratio of the number of bleeds to the number of days in the time interval multiplied by 365.25.
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
Results posted on
2025-05-04
Participant Flow
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose.
Sixty seven (67) participants were enrolled. Of those, 54 completed the Lead-in and were dosed with AMT-061.
Participant milestones
| Measure |
Lead-in Safety Population
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose.
The Lead-in Safety Population consisted of all subjects who were enrolled into the lead-in phase.
During the lead-in, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of Factor IX (FIX) replacement therapy and bleeding episodes in their dedicated e-diary. AMT-061 was administered after the Lead-in Period.
|
|---|---|
|
Lead-in
STARTED
|
67
|
|
Lead-in
COMPLETED
|
54
|
|
Lead-in
NOT COMPLETED
|
13
|
|
AMT-061
STARTED
|
54
|
|
AMT-061
COMPLETED
|
53
|
|
AMT-061
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Lead-in Safety Population
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose.
The Lead-in Safety Population consisted of all subjects who were enrolled into the lead-in phase.
During the lead-in, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of Factor IX (FIX) replacement therapy and bleeding episodes in their dedicated e-diary. AMT-061 was administered after the Lead-in Period.
|
|---|---|
|
Lead-in
Ineligible during lead-in
|
8
|
|
Lead-in
Withdrawal by Subject
|
3
|
|
Lead-in
Risks related to COVID-19
|
2
|
|
AMT-061
Adverse Event
|
1
|
Baseline Characteristics
HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients
Baseline characteristics by cohort
| Measure |
Safety Population
n=67 Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary. After the lead-in phase, subjects received a single-dose of AMT-061.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Lead-in period and months 7-18 post-treatment of AMT-061Population: Full Analysis Set (FAS) included all subjects who were enrolled, entered the lead-in phase, were dosed with AMT-061, and provided at least 1 efficacy endpoint assessment for any efficacy endpoint subsequent to AMT-061 dosing. Subjects who were Lead-in Discontinuers were not included in the FAS.
ABR was calculated as the ratio of the number of bleeds to the number of days in the time interval multiplied by 365.25.
Outcome measures
| Measure |
FIX (Lead-in)
n=54 Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
Annualized Bleeding Rate (ABR) for All Bleeding Episodes
|
4.19 bleeds/year/subject
Interval 3.22 to 5.45
|
1.51 bleeds/year/subject
Interval 0.81 to 2.82
|
SECONDARY outcome
Timeframe: Baseline and 6,12, and 18 months after AMT-061 dosingPopulation: FAS.
Outcome measures
| Measure |
FIX (Lead-in)
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
Factor IX Activity Levels After AMT-061 Dosing
Baseline
|
—
|
1.19 Factor IX activity (%)
Standard Deviation 0.39
|
|
Factor IX Activity Levels After AMT-061 Dosing
6 months
|
—
|
38.95 Factor IX activity (%)
Standard Deviation 18.72
|
|
Factor IX Activity Levels After AMT-061 Dosing
12 months
|
—
|
41.48 Factor IX activity (%)
Standard Deviation 21.71
|
|
Factor IX Activity Levels After AMT-061 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 dosingPopulation: FAS
Outcome measures
| Measure |
FIX (Lead-in)
n=54 Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
Annualized Exogenous Factor IX Consumption
Lead-in
|
257,338.8 IU/year
Standard Deviation 149,013.1
|
—
|
|
Annualized Exogenous Factor IX Consumption
Months 0-6
|
—
|
12,912.9 IU/year
Standard Deviation 37,093.1
|
|
Annualized Exogenous Factor IX Consumption
Months 7-12
|
—
|
8399.1 IU/year
Standard Deviation 29,720.9
|
|
Annualized Exogenous Factor IX Consumption
Months 13-18
|
—
|
8486.6 IU/year
Standard Deviation 28,770.2
|
SECONDARY outcome
Timeframe: Lead-in period and months 7-18 after AMT-061 dosingPopulation: FAS.
Outcome measures
| Measure |
FIX (Lead-in)
n=54 Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
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 dosingPopulation: FAS
Outcome measures
| Measure |
FIX (Lead-in)
n=54 Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
Percent of Subjects Who Discontinued FIX Prophylaxis and Remained Free of Routine FIX Prophylaxis After AMT-061 Dosing
|
96.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Lead-in and 3, 12, and 18 months after AMT-061 dosingPopulation: FAS
Outcome measures
| Measure |
FIX (Lead-in)
n=54 Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
Percentage of Subjects With Trough FIX Activity <12% of Normal
Lead-in
|
79.6 percentage of participants
|
—
|
|
Percentage of Subjects With Trough FIX Activity <12% of Normal
3 months
|
—
|
7.8 percentage of participants
|
|
Percentage of Subjects With Trough FIX Activity <12% of Normal
12 months
|
—
|
8.0 percentage of participants
|
|
Percentage of Subjects With Trough FIX Activity <12% of Normal
18 months
|
—
|
6.0 percentage of participants
|
SECONDARY outcome
Timeframe: Lead-in and Months 7-18 after AMT-061 dosingPopulation: FAS
Outcome measures
| Measure |
FIX (Lead-in)
n=54 Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
ABR for FIX-treated Bleeding Episodes
|
3.65 bleeds/year/subject
Interval 2.82 to 4.74
|
0.84 bleeds/year/subject
Interval 0.41 to 1.73
|
SECONDARY outcome
Timeframe: Lead-in period and months 7-18 after AMT-061 dosingPopulation: FAS
Outcome measures
| Measure |
FIX (Lead-in)
n=54 Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
Number of Spontaneous Bleeding Episodes
Lead-in
|
50 Number of bleeds
|
—
|
|
Number of Spontaneous Bleeding Episodes
Months 7-18
|
—
|
14 Number of bleeds
|
SECONDARY outcome
Timeframe: Lead-in period and months 7-18 after AMT-061 dosingPopulation: FAS
Outcome measures
| Measure |
FIX (Lead-in)
n=54 Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
Number of Joint Bleeding Episodes
Lead-in
|
77 Number of bleeds
|
—
|
|
Number of Joint Bleeding Episodes
Months 7-18
|
—
|
19 Number of bleeds
|
SECONDARY outcome
Timeframe: Baseline and 6,12, and 18 months after AMT-061 dosingPopulation: FAS
Outcome measures
| Measure |
FIX (Lead-in)
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=21 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
Mean FIX Activity (%) in Subjects With Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 Dosing
Baseline
|
—
|
1.24 Factor IX activity (%)
Standard Deviation 0.44
|
|
Mean FIX Activity (%) in Subjects With Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 Dosing
6 months
|
—
|
35.91 Factor IX activity (%)
Standard Deviation 19.02
|
|
Mean FIX Activity (%) in Subjects With Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 Dosing
12 months
|
—
|
35.54 Factor IX activity (%)
Standard Deviation 17.84
|
|
Mean FIX Activity (%) in Subjects With Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 Dosing
18 months
|
—
|
31.14 Factor IX activity (%)
Standard Deviation 13.75
|
SECONDARY outcome
Timeframe: Baseline and 6,12, and 18 months after AMT-061 dosingPopulation: FAS
Outcome measures
| Measure |
FIX (Lead-in)
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=33 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
Mean FIX Activity (%) in Subjects Without Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 Dosing
Baseline
|
—
|
1.15 Factor IX activity (%)
Standard Deviation 0.36
|
|
Mean FIX Activity (%) in Subjects Without Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 Dosing
6 months
|
—
|
40.61 Factor IX activity (%)
Standard Deviation 18.64
|
|
Mean FIX Activity (%) in Subjects Without Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 Dosing
12 months
|
—
|
44.82 Factor IX activity (%)
Standard Deviation 23.21
|
|
Mean FIX Activity (%) in Subjects Without Pre-Existing Neutralizing Antibodies to AAV5 After AMT-061 Dosing
18 months
|
—
|
39.87 Factor IX activity (%)
Standard Deviation 24.08
|
SECONDARY outcome
Timeframe: Up to 18 months after AT-061 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 |
FIX (Lead-in)
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
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-061Population: FAS
Outcome measures
| Measure |
FIX (Lead-in)
n=54 Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
Percent of Participants With Zero Bleeding Episodes During the 52 Weeks Following Stable FIX Expression (6 to 18 Months) After AMT-061 Dosing
|
25.9 percentage of participants
|
63.0 percentage of participants
|
SECONDARY outcome
Timeframe: Lead-in period and up to 12 months after AT-01 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 that that activity was undertaken. A higher score is considered to be more favorable.
Outcome measures
| Measure |
FIX (Lead-in)
n=54 Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
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 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 |
FIX (Lead-in)
n=54 Participants
During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 Participants
Single infusion of AMT-061
Subjects will receive a single infusion of AAV5-hFIXco-Padua (AMT- 061) at baseline after lead-in.
|
|---|---|---|
|
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: 5 yearsFollow up and assess any adverse events reported for safety
Outcome measures
Outcome data not reported
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
Serious events: 13 serious events
Other events: 53 other events
Deaths: 1 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), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
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), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 participants at risk
Single infusion of AMT-061 after lead-in.
|
|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Infections and infestations
COVID-19
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
General disorders
Complication Associated With Device
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Musculoskeletal and connective tissue disorders
Haemophilic arthropathy
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
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), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
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), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
|
AMT-061
n=54 participants at risk
Single infusion of AMT-061 after lead-in.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
5/67 • Number of events 5 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
7.4%
4/54 • Number of events 4 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
33.3%
18/54 • Number of events 31 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
13.0%
7/54 • Number of events 10 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
11.1%
6/54 • Number of events 7 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
7.4%
4/54 • Number of events 4 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
5.6%
3/54 • Number of events 3 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
General disorders
Fatigue
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
25.9%
14/54 • Number of events 16 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
General disorders
Influenza like illness
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
13.0%
7/54 • Number of events 11 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
General disorders
Pain
|
3.0%
2/67 • Number of events 2 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
7.4%
4/54 • Number of events 4 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
General disorders
Malaise
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
9.3%
5/54 • Number of events 7 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
General disorders
Chest pain
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
7.4%
4/54 • Number of events 4 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
General disorders
Chills
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
5.6%
3/54 • Number of events 3 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
General disorders
Pyrexia
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
5.6%
3/54 • Number of events 4 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Infections and infestations
Nasopharyngitis
|
11.9%
8/67 • Number of events 8 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
14.8%
8/54 • Number of events 8 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
27.8%
15/54 • Number of events 20 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Infections and infestations
Cystitis
|
3.0%
2/67 • Number of events 2 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
3.7%
2/54 • Number of events 2 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
5.6%
3/54 • Number of events 3 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Vascular disorders
Hypertension
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
7.4%
4/54 • Number of events 4 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Infections and infestations
COVID-19
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
5.6%
3/54 • Number of events 3 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Infections and infestations
Influenza
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
5.6%
3/54 • Number of events 3 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Gastrointestinal disorders
Nausea
|
3.0%
2/67 • Number of events 2 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
3.7%
2/54 • Number of events 2 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
11.1%
6/54 • Number of events 6 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
11.1%
6/54 • Number of events 6 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Gastrointestinal disorders
Toothache
|
3.0%
2/67 • Number of events 2 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
3.7%
2/54 • Number of events 2 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
7.4%
4/54 • Number of events 7 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
5.6%
3/54 • Number of events 4 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
5.6%
3/54 • Number of events 3 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Nervous system disorders
Headache
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
29.6%
16/54 • Number of events 31 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
7.4%
4/54 • Number of events 4 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
20.4%
11/54 • Number of events 12 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
14.8%
8/54 • Number of events 10 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
13.0%
7/54 • Number of events 8 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Investigations
C-reactive protein increased
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
7.4%
4/54 • Number of events 4 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.5%
3/67 • Number of events 3 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
3.7%
2/54 • Number of events 2 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
13.0%
7/54 • Number of events 7 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
11.1%
6/54 • Number of events 6 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
5.6%
3/54 • Number of events 3 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
2/67 • Number of events 2 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
7.4%
4/54 • Number of events 4 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
3.0%
2/67 • Number of events 2 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
3.7%
2/54 • Number of events 2 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
5.6%
3/54 • Number of events 3 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.5%
1/67 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
1.9%
1/54 • Number of events 1 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
7.4%
4/54 • Number of events 4 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
5.6%
3/54 • Number of events 3 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/67 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
0.00%
0/54 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
5.6%
3/54 • Number of events 4 • Up to 2 years per subject (up to 6 months Lead-in and up to an additional 18 months post-dose)
This is an 18-month post-dose interim analysis due to the completion of the primary endpoint. The study will complete approximately 5 years after post-dose. The Safety Population consisted of all subjects who were enrolled in either the Lead-in Safety Population (consisted of all subjects who were enrolled into the lead-in phase) or the Post-treatment Safety Population (consisted of all subjects who received AMT-061, irrespective of any protocol deviations).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place