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)
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)