Trial Outcomes & Findings for Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 (NCT NCT02159729)
NCT ID: NCT02159729
Last Updated: 2020-02-17
Results Overview
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
205 participants
Primary outcome timeframe
Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)
Results posted on
2020-02-17
Participant Flow
The objective of this non-treatment, placebo-controlled, 5-year follow-up study was to evaluate the long-term efficacy and safety of subcutaneous (SC) injections of deoxycholic acid (ATX-101) in the submental area. No treatment was administered in this study.
Participants who previously received deoxycholic acid or placebo injections in studies ATX-101-06-03, ATX-101-07-07, \& ATX-101-09-15 were enrolled in this non-treatment follow-up study to further evaluate safety and efficacy.
Participant milestones
| Measure |
ATX-101 (Deoxycholic Acid) Injection
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
Placebo
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
65
|
|
Overall Study
COMPLETED
|
98
|
44
|
|
Overall Study
NOT COMPLETED
|
42
|
21
|
Reasons for withdrawal
| Measure |
ATX-101 (Deoxycholic Acid) Injection
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
Placebo
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Subject's Request
|
13
|
10
|
|
Overall Study
Lost to Follow-up
|
24
|
9
|
|
Overall Study
Non compliance
|
2
|
0
|
|
Overall Study
Other Unspecified
|
3
|
1
|
Baseline Characteristics
Long Term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Baseline characteristics by cohort
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=140 Participants
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
Placebo
n=65 Participants
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.8 Years
STANDARD_DEVIATION 8.86 • n=99 Participants
|
48.2 Years
STANDARD_DEVIATION 9.94 • n=107 Participants
|
47.2 Years
STANDARD_DEVIATION 9.22 • n=206 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
131 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
187 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Baseline weight (kg)
|
80.64 kilogram (kg)
STANDARD_DEVIATION 16.683 • n=99 Participants
|
85.93 kilogram (kg)
STANDARD_DEVIATION 15.983 • n=107 Participants
|
82.32 kilogram (kg)
STANDARD_DEVIATION 16.610 • n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)Population: Analysis population included all who received study treatment from a previous study, and who were CR-SMFRS 1-Grade Responders at LTFU Baseline
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Outcome measures
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=104 Participants
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
Placebo
n=20 Participants
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
|---|---|---|
|
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Baseline
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 1 (Month 3)
|
93.1 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 2 (Month 6)
|
94.0 percentage of participants
|
68.8 percentage of participants
|
|
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 3 (Month 9)
|
94.9 percentage of participants
|
81.3 percentage of participants
|
|
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 4 (Month 12)
|
94.0 percentage of participants
|
82.4 percentage of participants
|
|
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 5 (Month 18)
|
95.1 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 6 (Month 24)
|
89.6 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 7 (Month 36)
|
80.8 percentage of participants
|
76.5 percentage of participants
|
|
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 8 (Month 48)
|
85.2 percentage of participants
|
64.3 percentage of participants
|
|
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 9 (Month 60)
|
71.2 percentage of participants
|
71.4 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)Population: Analysis population included all who received study treatment from a previous study, and who were PR-SMFRS 1-Grade Responders at LTFU Baseline
The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Outcome measures
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=41 Participants
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
Placebo
n=21 Participants
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
|---|---|---|
|
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Baseline
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 1 (Month 3)
|
94.7 percentage of participants
|
73.3 percentage of participants
|
|
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 2 (Month 6)
|
94.1 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 3 (Month 9)
|
87.5 percentage of participants
|
94.4 percentage of participants
|
|
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 4 (Month 12)
|
85.0 percentage of participants
|
94.4 percentage of participants
|
|
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 5 (Month 18)
|
80.6 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 6 (Month 24)
|
85.7 percentage of participants
|
82.4 percentage of participants
|
|
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 7 (Month 36)
|
81.8 percentage of participants
|
94.1 percentage of participants
|
|
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 8 (Month 48)
|
78.1 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 9 (Month 60)
|
84.8 percentage of participants
|
93.3 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)Population: Analysis population included all who received study treatment from a previous study, and who were composite SMFRS 1-Grade Responders at LTFU Baseline
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Outcome measures
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=30 Participants
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
Placebo
n=7 Participants
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
|---|---|---|
|
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Baseline
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 1 (Month 3)
|
84.6 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 2 (Month 6)
|
82.6 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 3 (Month 9)
|
82.8 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 4 (Month 12)
|
79.3 percentage of participants
|
71.4 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 5 (Month 18)
|
73.1 percentage of participants
|
71.4 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 6 (Month 24)
|
73.1 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 7 (Month 36)
|
65.2 percentage of participants
|
85.7 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 8 (Month 48)
|
60.9 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 9 (Month 60)
|
73.9 percentage of participants
|
83.3 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)Population: Analysis population included all who received study treatment from a previous study, and who were composite SMFRS 2-Grade Responders at LTFU Baseline
The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst). The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst). Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
Outcome measures
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=3 Participants
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
Placebo
n=1 Participants
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
|---|---|---|
|
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Baseline
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 1 (Month 3)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 2 (Month 6)
|
66.7 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 3 (Month 9)
|
66.7 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 4 (Month 12)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 5 (Month 18)
|
0.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 6 (Month 24)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 7 (Month 36)
|
100.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 8 (Month 48)
|
100.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 9 (Month 60)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
Adverse Events
ATX-101 (Deoxycholic Acid) Injection
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=140 participants at risk
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
Placebo
n=65 participants at risk
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 3 predecessor studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.71%
1/140 • Number of events 1 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
0.00%
0/65 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
|
Endocrine disorders
Asymptomatic cystic thyroid mass
|
0.71%
1/140 • Number of events 1 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
0.00%
0/65 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
|
Cardiac disorders
Third degree heart block
|
0.71%
1/140 • Number of events 1 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
0.00%
0/65 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Patient died of pancreatic cancer
|
0.00%
0/140 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
1.5%
1/65 • Number of events 1 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/140 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
1.5%
1/65 • Number of events 1 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/140 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
1.5%
1/65 • Number of events 1 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
|
Endocrine disorders
Thyroid cancer
|
0.00%
0/140 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
1.5%
1/65 • Number of events 1 • Up to 60 months from the last visit in the previous study
All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-06-03, ATX-101-07-07, and ATX-101-09-15, were followed until they resolved or were considered medically stable.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER