Trial Outcomes & Findings for Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 (NCT NCT02163902)
NCT ID: NCT02163902
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
PHASE3
Target enrollment
224 participants
Primary outcome timeframe
From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Results posted on
2020-02-17
Participant Flow
The objective of this non-treatment, double-blind, placebo-controlled 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-101-11-22 and ATX-101-11-23 were enrolled in this non-treatment, double-blind, placebo-controlled 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 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
|
Placebo
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
111
|
|
Overall Study
COMPLETED
|
102
|
98
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
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 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
|
Placebo
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
|
|---|---|---|
|
Overall Study
Subject's Request
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
|
Overall Study
Administrative Decision
|
2
|
2
|
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=113 Participants
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
|
Placebo
n=111 Participants
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 8.22 • n=99 Participants
|
50.1 years
STANDARD_DEVIATION 9.00 • n=107 Participants
|
50.6 years
STANDARD_DEVIATION 8.61 • n=206 Participants
|
|
Age, Customized
≤ 30 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Customized
> 30 to ≤ 50 years
|
52 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Age, Customized
> 50 years
|
58 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Age, Customized
< 50 years
|
47 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
191 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
33 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
166 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
197 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 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
|
|
Body Mass Index (BMI)
|
29.283 kg/m^2
STANDARD_DEVIATION 4.4934 • n=99 Participants
|
28.836 kg/m^2
STANDARD_DEVIATION 4.0099 • n=107 Participants
|
29.062 kg/m^2
STANDARD_DEVIATION 4.2570 • n=206 Participants
|
|
Fitzpatrick Score
I
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Fitzpatrick Score
II
|
30 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Fitzpatrick Score
III
|
33 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Fitzpatrick Score
IV
|
35 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Fitzpatrick Score
V
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Fitzpatrick Score
VI
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatmentPopulation: Participants who had at least a 1-grade reduction from baseline on the CRSMFRS (ie, CR-1 responder) at 12-weeks after last treatment in the predecessor studies.
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=95 Participants
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
|
Placebo
n=46 Participants
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
|
|---|---|---|
|
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 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 (Year 3) Percentage
|
82.4 percentage of participants
Interval 74.2 to 90.5
|
65.0 percentage of participants
Interval 50.2 to 79.8
|
|
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 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 (Year 1) Percentage
|
86.4 percentage of participants
Interval 79.2 to 93.5
|
56.8 percentage of participants
Interval 42.2 to 71.5
|
|
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 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 (Year 2) Percentage
|
90.6 percentage of participants
Interval 84.4 to 96.8
|
73.8 percentage of participants
Interval 60.5 to 87.1
|
SECONDARY outcome
Timeframe: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment.Population: Analysis Population: Participants who had at least a 2-grade reduction from baseline on the CR-SMFRS (ie, CR-2 responder) at 12-weeks after last treatment in the predecessor studies.
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=44 Participants
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
|
Placebo
n=12 Participants
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
|
|---|---|---|
|
Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 2 (Year 2) Percentage
|
72.5 percentage of participants
Interval 58.7 to 86.3
|
33.3 percentage of participants
Interval 2.5 to 64.1
|
|
Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 1 (Year 1) Percentage
|
75.0 percentage of participants
Interval 61.6 to 88.4
|
18.2 percentage of participants
Interval 0.0 to 41.0
|
|
Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 3 (Year 3) Percentage
|
65.8 percentage of participants
Interval 50.7 to 80.9
|
33.3 percentage of participants
Interval 2.5 to 64.1
|
SECONDARY outcome
Timeframe: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatmentPopulation: Analysis Population: Participants who had at least a 1-grade reduction from baseline in PR-SMFRS (ie, PR-1 responder) at 12-weeks after last treatment in the predecessor studies.
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=98 Participants
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
|
Placebo
n=58 Participants
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
|
|---|---|---|
|
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 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 (Year 1) Percentage
|
95.5 percentage of participants
Interval 91.1 to 99.8
|
76.4 percentage of participants
Interval 65.1 to 87.6
|
|
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 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 (Year 2) Percentage
|
87.8 percentage of participants
Interval 81.0 to 94.5
|
83.0 percentage of participants
Interval 72.9 to 93.1
|
|
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 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 (Year 3) Percentage
|
77.0 percentage of participants
Interval 68.2 to 85.9
|
75.0 percentage of participants
Interval 62.8 to 87.2
|
SECONDARY outcome
Timeframe: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatmentPopulation: Analysis Population: Participants who had at least a 2-grade reduction from baseline in PR-SMFRS (ie, PR-2 responder) at 12-weeks after last treatment in the predecessor studies.
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=43 Participants
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
|
Placebo
n=11 Participants
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
|
|---|---|---|
|
Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 2 (Year 2) Percentage
|
57.5 percentage of participants
Interval 42.2 to 72.8
|
60.0 percentage of participants
Interval 29.6 to 90.4
|
|
Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 3 (Year 3) Percentage
|
59.5 percentage of participants
Interval 43.6 to 75.3
|
70.0 percentage of participants
Interval 41.6 to 98.4
|
|
Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Visit 1 (Year 1) Percentage
|
59.0 percentage of participants
Interval 43.5 to 74.4
|
63.6 percentage of participants
Interval 35.2 to 92.1
|
SECONDARY outcome
Timeframe: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatmentPopulation: Analysis Population: Participants who were both CR-1 responders and PR-1 responders (SMFRS-1) at 12-weeks after last treatment in the predecessor studies.
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=83 Participants
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
|
Placebo
n=31 Participants
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
|
|---|---|---|
|
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 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 (Year 1) Percentage
|
86.8 percentage of participants
Interval 79.2 to 94.4
|
44.8 percentage of participants
Interval 26.7 to 62.9
|
|
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 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 (Year 2) Percentage
|
85.1 percentage of participants
Interval 77.0 to 93.2
|
64.3 percentage of participants
Interval 46.5 to 82.0
|
|
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 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 (Year 3) Percentage
|
72.6 percentage of participants
Interval 62.4 to 82.8
|
46.2 percentage of participants
Interval 27.0 to 65.3
|
SECONDARY outcome
Timeframe: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatmentPopulation: Analysis Population: Participants who were both CR-2 responders and PR-2 responders (SMFRS-2) at 12-weeks after last treatment in the predecessor studies.
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=18 Participants
This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
|
Placebo
n=3 Participants
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
|
|---|---|---|
|
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 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 (Year 1) Percentage
|
41.2 percentage of participants
Interval 17.8 to 64.6
|
0.0 percentage of participants
Of the 3 SMFRS-2 responders in the Placebo group 0 participants maintained response.
|
|
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 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 (Year 2) Percentage
|
43.8 percentage of participants
Interval 19.4 to 68.1
|
0.0 percentage of participants
Of the 3 SMFRS-2 responders in the Placebo group 0 participants maintained response.
|
|
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 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 (Year 3) Percentage
|
50.0 percentage of participants
Interval 23.8 to 76.2
|
50.0 percentage of participants
Interval 0.0 to 100.0
|
Adverse Events
ATX-101 (Deoxycholic Acid) Injection
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ATX-101 (Deoxycholic Acid) Injection
n=113 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 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.
|
Placebo
n=111 participants at risk
This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.88%
1/113 • Number of events 1 • From the first exposure to study drug in predecessor study to up to 36 months after last treatment in predecessor 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-101-11-22 and ATX-101-11-23 were followed until they resolved or were considered medically stable.
|
0.00%
0/111 • From the first exposure to study drug in predecessor study to up to 36 months after last treatment in predecessor 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-101-11-22 and ATX-101-11-23 were followed until they resolved or were considered medically stable.
|
|
Gastrointestinal disorders
Diverticulitis
|
1.8%
2/113 • Number of events 2 • From the first exposure to study drug in predecessor study to up to 36 months after last treatment in predecessor 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-101-11-22 and ATX-101-11-23 were followed until they resolved or were considered medically stable.
|
0.00%
0/111 • From the first exposure to study drug in predecessor study to up to 36 months after last treatment in predecessor 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-101-11-22 and ATX-101-11-23 were followed until they resolved or were considered medically stable.
|
|
Surgical and medical procedures
Breast reconstruction
|
1.0%
1/96 • Number of events 1 • From the first exposure to study drug in predecessor study to up to 36 months after last treatment in predecessor 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-101-11-22 and ATX-101-11-23 were followed until they resolved or were considered medically stable.
|
0.00%
0/95 • From the first exposure to study drug in predecessor study to up to 36 months after last treatment in predecessor 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-101-11-22 and ATX-101-11-23 were followed until they resolved or were considered medically stable.
|
|
Reproductive system and breast disorders
Ovarian cancer recurrent
|
1.0%
1/96 • Number of events 1 • From the first exposure to study drug in predecessor study to up to 36 months after last treatment in predecessor 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-101-11-22 and ATX-101-11-23 were followed until they resolved or were considered medically stable.
|
0.00%
0/95 • From the first exposure to study drug in predecessor study to up to 36 months after last treatment in predecessor 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-101-11-22 and ATX-101-11-23 were followed until they resolved or were considered medically stable.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/96 • From the first exposure to study drug in predecessor study to up to 36 months after last treatment in predecessor 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-101-11-22 and ATX-101-11-23 were followed until they resolved or were considered medically stable.
|
1.1%
1/95 • Number of events 1 • From the first exposure to study drug in predecessor study to up to 36 months after last treatment in predecessor 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-101-11-22 and ATX-101-11-23 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