ID

3738

Description

ODM derived from http://clinicaltrials.gov/show/NCT01294644

Link

http://clinicaltrials.gov/show/NCT01294644

Keywords

Versions (2)
  1. 2/28/13 2/28/13 - Martin Dugas
  2. 9/20/21 9/20/21 -
Uploaded on

February 28, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01294644 Healthy

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age 18 Years to 65 Years
Description

age 18 Years to 65 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) as determined on Visit 2.
Description

Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) as determined on Visit 2.

Data type

boolean

Alias
UMLS CUI 2011AA
C0542339
SNOMED CT 2011_0131
351726001, 261089000
UMLS CUI 2011AA
C0008114
SNOMED CT 2011_0131
30291003
UMLS CUI 2011AA
CL429588
UMLS CUI 2011AA
C1522446
UMLS CUI 2011AA
C0450094
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0681889
Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS).
Description

Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS).

Data type

boolean

Alias
UMLS CUI 2011AA
C0870433
UMLS CUI 2011AA
C0222371
SNOMED CT 2011_0131
7840002
UMLS CUI 2011AA
C0871208
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0681889
Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive on the day of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before randomization and agree to practice medically acceptable birth control during the course of the study. Medically acceptable birth control includes: surgical sterilization, hormonal contraceptives, barrier methods or an intrauterine device (IUD).
Description

Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive on the day of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before randomization and agree to practice medically acceptable birth control during the course of the study. Medically acceptable birth control includes: surgical sterilization, hormonal contraceptives, barrier methods or an intrauterine device (IUD).

Data type

boolean

Alias
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0232973
SNOMED CT 2011_0131
60001007
UMLS CUI 2011AA
C2826207
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
CL429973
MedDRA 14.1
10071333
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0015787
SNOMED CT 2011_0131
169549004
MedDRA 14.1
10056199
UMLS CUI 2011AA
CL424941
UMLS CUI 2011AA
C0558251
SNOMED CT 2011_0131
275832008
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. No significant change, in the judgment of the investigator, in diet or exercise practices for at least 6 months before randomization and agreement to not change diet or exercise practices during the course of the study.
Description

History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. No significant change, in the judgment of the investigator, in diet or exercise practices for at least 6 months before randomization and agreement to not change diet or exercise practices during the course of the study.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0005910
SNOMED CT 2011_0131
27113001
LOINC Version 232
MTHU001885
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0392747
SNOMED CT 2011_0131
243326001
UMLS CUI 2011AA
C0012155
SNOMED CT 2011_0131
41829006
UMLS CUI 2011AA
C0015259
SNOMED CT 2011_0131
256235009
MedDRA 14.1
10015634
Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures.
Description

Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures.

Data type

boolean

Alias
UMLS CUI 2011AA
C0162340
SNOMED CT 2011_0131
66216009
UMLS CUI 2011AA
C1554196
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0086960
UMLS CUI 2011AA
C0525058
Medically able to undergo the administration of study material determined by clinical evaluations made within 56 days before and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality.
Description

Medically able to undergo the administration of study material determined by clinical evaluations made within 56 days before and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0001554
SNOMED CT 2011_0131
413454004
UMLS CUI 2011AA
C2985618
UMLS CUI 2011AA
C1261322
SNOMED CT 2011_0131
386053000
MedDRA 14.1
10062026
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0438215
SNOMED CT 2011_0131
165346000
MedDRA 14.1
10023547
Signed informed consent obtained before any study-specific procedure is performed.
Description

Signed informed consent obtained before any study-specific procedure is performed.

Data type

boolean

Alias
UMLS CUI 2011AA
C1301820
SNOMED CT 2011_0131
398092000
UMLS CUI 2011AA
C1519316
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.
Description

History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C1948041
SNOMED CT 2011_0131
71388002
MedDRA 14.1
10042613
LOINC Version 232
MTHU006237
ICD-9-CM Version 2011
00-99.99
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0542339
SNOMED CT 2011_0131
351726001, 261089000
UMLS CUI 2011AA
C0008114
SNOMED CT 2011_0131
30291003
UMLS CUI 2011AA
CL429588
UMLS CUI 2011AA
C0038640
SNOMED CT 2011_0131
302441008
MedDRA 14.1
10048701
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0023796
SNOMED CT 2011_0131
34785007
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
C0175677
SNOMED CT 2011_0131
417746004
MedDRA 14.1
10022116
ICD-10-CM Version 2010
T14.9
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0008114
SNOMED CT 2011_0131
30291003
UMLS CUI 2011AA
C0027530
SNOMED CT 2011_0131
45048000
LOINC Version 232
MTHU002688
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS, Appendix C2).
Description

Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS, Appendix C2).

Data type

boolean

Alias
UMLS CUI 2011AA
C0010495
SNOMED CT 2011_0131
58588007
MedDRA 14.1
10011692
ICD-10-CM Version 2010
Q82.8
UMLS CUI 2011AA
C0027530
SNOMED CT 2011_0131
45048000
LOINC Version 232
MTHU002688
UMLS CUI 2011AA
C0008114
SNOMED CT 2011_0131
30291003
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0681889
Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome.
Description

Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205402
SNOMED CT 2011_0131
4657009
UMLS CUI 2011AA
C0224176
SNOMED CT 2011_0131
18252004
UMLS CUI 2011AA
CL419362
UMLS CUI 2011AA
C0443144
SNOMED CT 2011_0131
263678003
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0502371
SNOMED CT 2011_0131
91805003
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C0542339
SNOMED CT 2011_0131
351726001, 261089000
UMLS CUI 2011AA
C0008114
SNOMED CT 2011_0131
30291003
UMLS CUI 2011AA
CL429588
UMLS CUI 2011AA
C1883420
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.
Description

Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.

Data type

boolean

Alias
UMLS CUI 2011AA
CL406656
UMLS CUI 2011AA
C0542339
SNOMED CT 2011_0131
351726001, 261089000
UMLS CUI 2011AA
C0008114
SNOMED CT 2011_0131
30291003
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C0018021
SNOMED CT 2011_0131
3716002
MedDRA 14.1
10018498
ICD-10-CM Version 2010
E04.9
ICD-9-CM Version 2011
240.9
UMLS CUI 2011AA
C0235592
SNOMED CT 2011_0131
127086001
MedDRA 14.1
10025200
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0392752
SNOMED CT 2011_0131
255471002
UMLS CUI 2011AA
C0542339
SNOMED CT 2011_0131
351726001, 261089000
UMLS CUI 2011AA
C0008114
SNOMED CT 2011_0131
30291003
UMLS CUI 2011AA
CL429588
Body mass index
Description

Body mass index (BMI) > 30 (Appendix B1).

Data type

boolean

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
Currently on or considering starting a weight reduction regimen.
Description

Currently on or considering starting a weight reduction regimen.

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0311130
SNOMED CT 2011_0131
388976009
Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
Description

Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.

Data type

boolean

Alias
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C0035204
SNOMED CT 2011_0131
50043002
MedDRA 14.1
10038683
ICD-10-CM Version 2010
J98.9
ICD-9-CM Version 2011
519.9
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
C0027765
SNOMED CT 2011_0131
118940003
MedDRA 14.1
10029202
ICD-10-CM Version 2010
G98.8
ICD-9-CM Version 2011
349.9
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C0348024
SNOMED CT 2011_0131
264580006
MedDRA 14.1
10013907
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0525058
UMLS CUI 2011AA
C0184704
SNOMED CT 2011_0131
55149002
Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections in the neck or chin area within 6 months before randomization.
Description

Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections in the neck or chin area within 6 months before randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0034547
SNOMED CT 2011_0131
52799000
UMLS CUI 2011AA
C1562720
SNOMED CT 2011_0131
416376001
UMLS CUI 2011AA
C0007979
SNOMED CT 2011_0131
31459005
MedDRA 14.1
10064840
UMLS CUI 2011AA
C2958948
MedDRA 14.1
10072349
UMLS CUI 2011AA
C0006055
SNOMED CT 2011_0131
11894001
LOINC Version 232
MTHU002713
UMLS CUI 2011AA
C1533685
SNOMED CT 2011_0131
59108006
MedDRA 14.1
10052995
UMLS CUI 2011AA
C0027530
SNOMED CT 2011_0131
45048000
LOINC Version 232
MTHU002688
UMLS CUI 2011AA
C0008114
SNOMED CT 2011_0131
30291003
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine).
Description

History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine).

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0036667
UMLS CUI 2011AA
C1705248
UMLS CUI 2011AA
C2985618
UMLS CUI 2011AA
C0040464
SNOMED CT 2011_0131
373520001
UMLS CUI 2011AA
C0002934
SNOMED CT 2011_0131
373477003
UMLS CUI 2011AA
C0023660
SNOMED CT 2011_0131
387480006
LOINC Version 232
MTHU005009
UMLS CUI 2011AA
C0005059
SNOMED CT 2011_0131
387357002
UMLS CUI 2011AA
C0358490
SNOMED CT 2011_0131
73444000
Previous randomization into this study or previous treatment with ATX-101.
Description

Previous randomization into this study or previous treatment with ATX-101.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Treatment with an investigational device or agent within 30 days of randomization.
Description

Treatment with an investigational device or agent within 30 days of randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0034656
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age 18 Years to 65 Years
Item
age 18 Years to 65 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) as determined on Visit 2.
Item
Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) as determined on Visit 2.
boolean
C0542339 (UMLS CUI 2011AA)
351726001, 261089000 (SNOMED CT 2011_0131)
C0008114 (UMLS CUI 2011AA)
30291003 (SNOMED CT 2011_0131)
CL429588 (UMLS CUI 2011AA)
C1522446 (UMLS CUI 2011AA)
C0450094 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0681889 (UMLS CUI 2011AA)
Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS).
Item
Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS).
boolean
C0870433 (UMLS CUI 2011AA)
C0222371 (UMLS CUI 2011AA)
7840002 (SNOMED CT 2011_0131)
C0871208 (UMLS CUI 2011AA)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0681889 (UMLS CUI 2011AA)
Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive on the day of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before randomization and agree to practice medically acceptable birth control during the course of the study. Medically acceptable birth control includes: surgical sterilization, hormonal contraceptives, barrier methods or an intrauterine device (IUD).
Item
Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive on the day of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before randomization and agree to practice medically acceptable birth control during the course of the study. Medically acceptable birth control includes: surgical sterilization, hormonal contraceptives, barrier methods or an intrauterine device (IUD).
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0232973 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
C2826207 (UMLS CUI 2011AA)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
CL429973 (UMLS CUI 2011AA)
10071333 (MedDRA 14.1)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0015787 (UMLS CUI 2011AA)
169549004 (SNOMED CT 2011_0131)
10056199 (MedDRA 14.1)
CL424941 (UMLS CUI 2011AA)
C0558251 (UMLS CUI 2011AA)
275832008 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. No significant change, in the judgment of the investigator, in diet or exercise practices for at least 6 months before randomization and agreement to not change diet or exercise practices during the course of the study.
Item
History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. No significant change, in the judgment of the investigator, in diet or exercise practices for at least 6 months before randomization and agreement to not change diet or exercise practices during the course of the study.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0015259 (UMLS CUI 2011AA)
256235009 (SNOMED CT 2011_0131)
10015634 (MedDRA 14.1)
Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures.
Item
Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures.
boolean
C0162340 (UMLS CUI 2011AA)
66216009 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
C0525058 (UMLS CUI 2011AA)
Medically able to undergo the administration of study material determined by clinical evaluations made within 56 days before and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality.
Item
Medically able to undergo the administration of study material determined by clinical evaluations made within 56 days before and laboratory tests obtained within 28 days before randomization for which the investigator identified no clinically significant abnormality.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0001554 (UMLS CUI 2011AA)
413454004 (SNOMED CT 2011_0131)
C2985618 (UMLS CUI 2011AA)
C1261322 (UMLS CUI 2011AA)
386053000 (SNOMED CT 2011_0131)
10062026 (MedDRA 14.1)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
Signed informed consent obtained before any study-specific procedure is performed.
Item
Signed informed consent obtained before any study-specific procedure is performed.
boolean
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C1519316 (UMLS CUI 2011AA)
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.
Item
History of any intervention to treat submental fat (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1948041 (UMLS CUI 2011AA)
71388002 (SNOMED CT 2011_0131)
10042613 (MedDRA 14.1)
MTHU006237 (LOINC Version 232)
00-99.99 (ICD-9-CM Version 2011)
CL415147 (UMLS CUI 2011AA)
C0542339 (UMLS CUI 2011AA)
351726001, 261089000 (SNOMED CT 2011_0131)
C0008114 (UMLS CUI 2011AA)
30291003 (SNOMED CT 2011_0131)
CL429588 (UMLS CUI 2011AA)
C0038640 (UMLS CUI 2011AA)
302441008 (SNOMED CT 2011_0131)
10048701 (MedDRA 14.1)
C0038895 (UMLS CUI 2011AA)
C0023796 (UMLS CUI 2011AA)
34785007 (SNOMED CT 2011_0131)
C1254351 (UMLS CUI 2011AA)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0008114 (UMLS CUI 2011AA)
30291003 (SNOMED CT 2011_0131)
C0027530 (UMLS CUI 2011AA)
45048000 (SNOMED CT 2011_0131)
MTHU002688 (LOINC Version 232)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS, Appendix C2).
Item
Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS, Appendix C2).
boolean
C0010495 (UMLS CUI 2011AA)
58588007 (SNOMED CT 2011_0131)
10011692 (MedDRA 14.1)
Q82.8 (ICD-10-CM Version 2010)
C0027530 (UMLS CUI 2011AA)
45048000 (SNOMED CT 2011_0131)
MTHU002688 (LOINC Version 232)
C0008114 (UMLS CUI 2011AA)
30291003 (SNOMED CT 2011_0131)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0681889 (UMLS CUI 2011AA)
Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome.
Item
Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome.
boolean
C0205402 (UMLS CUI 2011AA)
4657009 (SNOMED CT 2011_0131)
C0224176 (UMLS CUI 2011AA)
18252004 (SNOMED CT 2011_0131)
CL419362 (UMLS CUI 2011AA)
C0443144 (UMLS CUI 2011AA)
263678003 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0502371 (UMLS CUI 2011AA)
91805003 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0220825 (UMLS CUI 2011AA)
C0542339 (UMLS CUI 2011AA)
351726001, 261089000 (SNOMED CT 2011_0131)
C0008114 (UMLS CUI 2011AA)
30291003 (SNOMED CT 2011_0131)
CL429588 (UMLS CUI 2011AA)
C1883420 (UMLS CUI 2011AA)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.
Item
Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.
boolean
CL406656 (UMLS CUI 2011AA)
C0542339 (UMLS CUI 2011AA)
351726001, 261089000 (SNOMED CT 2011_0131)
C0008114 (UMLS CUI 2011AA)
30291003 (SNOMED CT 2011_0131)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0018021 (UMLS CUI 2011AA)
3716002 (SNOMED CT 2011_0131)
10018498 (MedDRA 14.1)
E04.9 (ICD-10-CM Version 2010)
240.9 (ICD-9-CM Version 2011)
C0235592 (UMLS CUI 2011AA)
127086001 (SNOMED CT 2011_0131)
10025200 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
C0392752 (UMLS CUI 2011AA)
255471002 (SNOMED CT 2011_0131)
C0542339 (UMLS CUI 2011AA)
351726001, 261089000 (SNOMED CT 2011_0131)
C0008114 (UMLS CUI 2011AA)
30291003 (SNOMED CT 2011_0131)
CL429588 (UMLS CUI 2011AA)
Body mass index (BMI) > 30 (Appendix B1).
Item
Body mass index
boolean
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Currently on or considering starting a weight reduction regimen.
Item
Currently on or considering starting a weight reduction regimen.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0311130 (UMLS CUI 2011AA)
388976009 (SNOMED CT 2011_0131)
Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
Item
Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0035204 (UMLS CUI 2011AA)
50043002 (SNOMED CT 2011_0131)
10038683 (MedDRA 14.1)
J98.9 (ICD-10-CM Version 2010)
519.9 (ICD-9-CM Version 2011)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0348024 (UMLS CUI 2011AA)
264580006 (SNOMED CT 2011_0131)
10013907 (MedDRA 14.1)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
C0184704 (UMLS CUI 2011AA)
55149002 (SNOMED CT 2011_0131)
Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections in the neck or chin area within 6 months before randomization.
Item
Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections in the neck or chin area within 6 months before randomization.
boolean
C0039798 (UMLS CUI 2011AA)
C0034547 (UMLS CUI 2011AA)
52799000 (SNOMED CT 2011_0131)
C1562720 (UMLS CUI 2011AA)
416376001 (SNOMED CT 2011_0131)
C0007979 (UMLS CUI 2011AA)
31459005 (SNOMED CT 2011_0131)
10064840 (MedDRA 14.1)
C2958948 (UMLS CUI 2011AA)
10072349 (MedDRA 14.1)
C0006055 (UMLS CUI 2011AA)
11894001 (SNOMED CT 2011_0131)
MTHU002713 (LOINC Version 232)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0027530 (UMLS CUI 2011AA)
45048000 (SNOMED CT 2011_0131)
MTHU002688 (LOINC Version 232)
C0008114 (UMLS CUI 2011AA)
30291003 (SNOMED CT 2011_0131)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine).
Item
History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine).
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0036667 (UMLS CUI 2011AA)
C1705248 (UMLS CUI 2011AA)
C2985618 (UMLS CUI 2011AA)
C0040464 (UMLS CUI 2011AA)
373520001 (SNOMED CT 2011_0131)
C0002934 (UMLS CUI 2011AA)
373477003 (SNOMED CT 2011_0131)
C0023660 (UMLS CUI 2011AA)
387480006 (SNOMED CT 2011_0131)
MTHU005009 (LOINC Version 232)
C0005059 (UMLS CUI 2011AA)
387357002 (SNOMED CT 2011_0131)
C0358490 (UMLS CUI 2011AA)
73444000 (SNOMED CT 2011_0131)
Previous randomization into this study or previous treatment with ATX-101.
Item
Previous randomization into this study or previous treatment with ATX-101.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Treatment with an investigational device or agent within 30 days of randomization.
Item
Treatment with an investigational device or agent within 30 days of randomization.
boolean
C0039798 (UMLS CUI 2011AA)
C2346570 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
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