Eligibility NCT00402727 Abscess
ODM derived from http://clinicaltrials.gov/show/NCT00402727

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Written informed consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Men or women of 18 years and above with a diagnosis of bacterial skin and skin structure infection that requires
Item
Men or women of 18 years and above with a diagnosis of bacterial skin and skin structure infection that requires
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0162627 (UMLS CUI 2011AA)
128936008 (SNOMED CT 2011_0131)
10052891 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
Hospitalization and
Item
Inpatient care (regime/therapy)
boolean
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
Initial parenteral therapy for at least 48 hours and
Item
Initial parenteral therapy for at least 48 hours and
boolean
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C1518896 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
Meets at least one of the following criteria:
Item
Meets at least one of the following criteria:
boolean
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Involvement of deep soft tissue (e.g. fascial, muscle layers)
Item
Involvement of deep soft tissue (e.g. fascial, muscle layers)
boolean
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0205125 (UMLS CUI 2011AA)
795002 (SNOMED CT 2011_0131)
C0225317 (UMLS CUI 2011AA)
87784001 (SNOMED CT 2011_0131)
MTHU016974 (LOINC Version 232)
C1268198 (UMLS CUI 2011AA)
120576005 (SNOMED CT 2011_0131)
C0225358 (UMLS CUI 2011AA)
86915006 (SNOMED CT 2011_0131)
Requirement for a significant surgical intervention including surgical drainage, drainage procedure guided by imaging and/or debridement
Item
Requirement for a significant surgical intervention including surgical drainage, drainage procedure guided by imaging and/or debridement
boolean
C1514873 (UMLS CUI 2011AA)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
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)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
C0969690 (UMLS CUI 2011AA)
C0011079 (UMLS CUI 2011AA)
36777000 (SNOMED CT 2011_0131)
10067806 (MedDRA 14.1)
Association with a significant underlying disease that may complicate response to treatment. An underlying disease is considered significant if it includes any of the following conditions that are present at the time of presentation: cancer (except basal- or squamous-cell cancer of the skin), cardiac (i.e., congestive heart disease), diabetes mellitus, hepatic (i.e., cirrhosis or another form of chronic liver disease), immunologic, renal disease, respiratory, transplantation or vascular disease
Item
Association with a significant underlying disease that may complicate response to treatment. An underlying disease is considered significant if it includes any of the following conditions that are present at the time of presentation: cancer (except basal- or squamous-cell cancer of the skin), cardiac (i.e., congestive heart disease), diabetes mellitus, hepatic (i.e., cirrhosis or another form of chronic liver disease), immunologic, renal disease, respiratory, transplantation or vascular disease
boolean
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0009566 (UMLS CUI 2011AA)
116223007 (SNOMED CT 2011_0131)
MTHU008883 (LOINC Version 232)
C0521982 (UMLS CUI 2011AA)
182985004 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C1522601 (UMLS CUI 2011AA)
C0018802 (UMLS CUI 2011AA)
42343007 (SNOMED CT 2011_0131)
10007559 (MedDRA 14.1)
MTHU020787 (LOINC Version 232)
I50.9 (ICD-10-CM Version 2010)
428.0 (ICD-9-CM Version 2011)
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
C0023890 (UMLS CUI 2011AA)
19943007 (SNOMED CT 2011_0131)
10019641 (MedDRA 14.1)
K74.60 (ICD-10-CM Version 2010)
C0341439 (UMLS CUI 2011AA)
328383001 (SNOMED CT 2011_0131)
10008953 (MedDRA 14.1)
C0205470 (UMLS CUI 2011AA)
37523008 (SNOMED CT 2011_0131)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
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)
C0040732 (UMLS CUI 2011AA)
77465005 (SNOMED CT 2011_0131)
10057677 (MedDRA 14.1)
C0042373 (UMLS CUI 2011AA)
27550009 (SNOMED CT 2011_0131)
10047062 (MedDRA 14.1)
Duration of infection < 21 days
Item
Duration of infection < 21 days
boolean
C0449238 (UMLS CUI 2011AA)
103335007 (SNOMED CT 2011_0131)
MTHU001938 (LOINC Version 232)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
Diagnosis of one of the following skin and skin structure infections that requires hospitalization and initial parenteral antibiotic therapy for at least 48 hours:
Item
Diagnosis of one of the following skin and skin structure infections that requires hospitalization and initial parenteral antibiotic therapy for at least 48 hours:
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
C1514873 (UMLS CUI 2011AA)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
C0205265 (UMLS CUI 2011AA)
884001 (SNOMED CT 2011_0131)
C1518896 (UMLS CUI 2011AA)
C0338237 (UMLS CUI 2011AA)
281789004 (SNOMED CT 2011_0131)
10067768 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
Major abscess(es) associated with extensive cellulitis, which requires antibiotic therapy in addition to surgical incision and drainage
Item
Major abscess(es) associated with extensive cellulitis, which requires antibiotic therapy in addition to surgical incision and drainage
boolean
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0000833 (UMLS CUI 2011AA)
128477000 (SNOMED CT 2011_0131)
10000269 (MedDRA 14.1)
MTHU022414 (LOINC Version 232)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0205231 (UMLS CUI 2011AA)
41118005 (SNOMED CT 2011_0131)
C0007642 (UMLS CUI 2011AA)
128045006 (SNOMED CT 2011_0131)
10007882 (MedDRA 14.1)
L03.90 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C0338237 (UMLS CUI 2011AA)
281789004 (SNOMED CT 2011_0131)
10067768 (MedDRA 14.1)
C0332287 (UMLS CUI 2011AA)
20401003 (SNOMED CT 2011_0131)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
Diabetic foot infection of mild to severe intensity (perfusion, extent/size, depth/tissue loss, infection and sensation (PEDIS) grade 2-4) in the presence or absence of osteomyelitis. Subjects with osteomyelitis may only be enrolled if the infected bone is completely removed by surgery and if residual infection requiring antibiotics is still present following surgery
Item
Diabetic foot infection of mild to severe intensity (perfusion, extent/size, depth/tissue loss, infection and sensation (PEDIS) grade 2-4) in the presence or absence of osteomyelitis. Subjects with osteomyelitis may only be enrolled if the infected bone is completely removed by surgery and if residual infection requiring antibiotics is still present following surgery
boolean
C0744130 (UMLS CUI 2011AA)
10060803 (MedDRA 14.1)
C2945599 (UMLS CUI 2011AA)
255604002 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0522510 (UMLS CUI 2011AA)
103370009 (SNOMED CT 2011_0131)
C0031001 (UMLS CUI 2011AA)
88058003 (SNOMED CT 2011_0131)
C0439792 (UMLS CUI 2011AA)
260858005 (SNOMED CT 2011_0131)
C0456389 (UMLS CUI 2011AA)
246115007 (SNOMED CT 2011_0131)
MTHU010347 (LOINC Version 232)
CL414326 (UMLS CUI 2011AA)
246171009 (SNOMED CT 2011_0131)
MTHU017832 (LOINC Version 232)
C0040300 (UMLS CUI 2011AA)
85756007 (SNOMED CT 2011_0131)
C1517945 (UMLS CUI 2011AA)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0036658 (UMLS CUI 2011AA)
373713005 (SNOMED CT 2011_0131)
MTHU017277 (LOINC Version 232)
C1522446 (UMLS CUI 2011AA)
C0450094 (UMLS CUI 2011AA)
C0547054 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0029443 (UMLS CUI 2011AA)
60168000 (SNOMED CT 2011_0131)
10031252 (MedDRA 14.1)
M86.9 (ICD-10-CM Version 2010)
730.20 (ICD-9-CM Version 2011)
C1516879 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C2242472 (UMLS CUI 2011AA)
111253001 (SNOMED CT 2011_0131)
M86.9 (ICD-10-CM Version 2010)
730.9 (ICD-9-CM Version 2011)
E11314 (CTCAE 1105E)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C1609982 (UMLS CUI 2011AA)
65320000 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0038895 (UMLS CUI 2011AA)
Wound infection including: post surgical (surgical incision), post-traumatic, human bite/clenched fist and animal bite wound and wound associated with injection drug abuse:
Item
Wound infection including: post surgical (surgical incision), post-traumatic, human bite/clenched fist and animal bite wound and wound associated with injection drug abuse:
boolean
C0043241 (UMLS CUI 2011AA)
76844004 (SNOMED CT 2011_0131)
10048038 (MedDRA 14.1)
MTHU020838 (LOINC Version 232)
E11635 (CTCAE 1105E)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0038941 (UMLS CUI 2011AA)
58126003 (SNOMED CT 2011_0131)
10036410 (MedDRA 14.1)
C1264517 (UMLS CUI 2011AA)
269406001 (SNOMED CT 2011_0131)
10036317 (MedDRA 14.1)
C0005660 (UMLS CUI 2011AA)
242605002 (SNOMED CT 2011_0131)
10020428 (MedDRA 14.1)
W50.3 (ICD-10-CM Version 2010)
E928.3 (ICD-9-CM Version 2011)
C1302713 (UMLS CUI 2011AA)
399907009 (SNOMED CT 2011_0131)
C0043250 (UMLS CUI 2011AA)
13924000 (SNOMED CT 2011_0131)
10052428 (MedDRA 14.1)
MTHU001326 (LOINC Version 232)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Infections must have occurred within 30 days of a surgical procedure, trauma, animal bite, or human bite, and involve the skin and skin structures at the site of the incision, trauma, or bite
Item
Infections must have occurred within 30 days of a surgical procedure, trauma, animal bite, or human bite, and involve the skin and skin structures at the site of the incision, trauma, or bite
boolean
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0243132 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0038895 (UMLS CUI 2011AA)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0003044 (UMLS CUI 2011AA)
418975000 (SNOMED CT 2011_0131)
10002515 (MedDRA 14.1)
E906.5 (ICD-9-CM Version 2011)
C0005660 (UMLS CUI 2011AA)
242605002 (SNOMED CT 2011_0131)
10020428 (MedDRA 14.1)
W50.3 (ICD-10-CM Version 2010)
E928.3 (ICD-9-CM Version 2011)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C1123023 (UMLS CUI 2011AA)
39937001 (SNOMED CT 2011_0131)
MTHU001414 (LOINC Version 232)
C0205145 (UMLS CUI 2011AA)
10546003 (SNOMED CT 2011_0131)
MTHU014632 (LOINC Version 232)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0005658 (UMLS CUI 2011AA)
3404009 (SNOMED CT 2011_0131)
10004966 (MedDRA 14.1)
In addition, post-surgical/trauma wound infections must meet the following criteria:
Item
In addition, post-surgical/trauma wound infections must meet the following criteria:
boolean
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0038941 (UMLS CUI 2011AA)
58126003 (SNOMED CT 2011_0131)
10036410 (MedDRA 14.1)
C0332663 (UMLS CUI 2011AA)
263904004 (SNOMED CT 2011_0131)
C0043241 (UMLS CUI 2011AA)
76844004 (SNOMED CT 2011_0131)
10048038 (MedDRA 14.1)
MTHU020838 (LOINC Version 232)
E11635 (CTCAE 1105E)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Involvement of deep soft tissues (e.g. fascial and muscle layers) of the incision/trauma
Item
Involvement of deep soft tissues (e.g. fascial and muscle layers) of the incision/trauma
boolean
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0205125 (UMLS CUI 2011AA)
795002 (SNOMED CT 2011_0131)
C0225317 (UMLS CUI 2011AA)
87784001 (SNOMED CT 2011_0131)
MTHU016974 (LOINC Version 232)
C1268198 (UMLS CUI 2011AA)
120576005 (SNOMED CT 2011_0131)
C0225358 (UMLS CUI 2011AA)
86915006 (SNOMED CT 2011_0131)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
At least one of the following criteria:
Item
At least one of the following criteria:
boolean
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Purulent drainage from the deep incision/trauma
Item
Purulent drainage from the deep incision/trauma
boolean
C0439665 (UMLS CUI 2011AA)
255316004 (SNOMED CT 2011_0131)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
C0205125 (UMLS CUI 2011AA)
795002 (SNOMED CT 2011_0131)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
Identification of an infecting organism from an aseptically obtained culture of fluid or tissue from incision/trauma
Item
Identification of an infecting organism from an aseptically obtained culture of fluid or tissue from incision/trauma
boolean
C0205396 (UMLS CUI 2011AA)
7882003 (SNOMED CT 2011_0131)
MTHU014964 (LOINC Version 232)
C0029235 (UMLS CUI 2011AA)
410653004 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0232920 (UMLS CUI 2011AA)
261029002, 260984003 (SNOMED CT 2011_0131)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C0430400 (UMLS CUI 2011AA)
252398009 (SNOMED CT 2011_0131)
10061447 (MedDRA 14.1)
CL427986 (UMLS CUI 2011AA)
C0040284 (UMLS CUI 2011AA)
77601007 (SNOMED CT 2011_0131)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
At least one of the following signs and symptoms:
Item
At least one of the following signs and symptoms:
boolean
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0220912 (UMLS CUI 2011AA)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
Localized pain or tenderness
Item
Localized pain or tenderness
boolean
C0520962 (UMLS CUI 2011AA)
112104007 (SNOMED CT 2011_0131)
10069139 (MedDRA 14.1)
C0392752 (UMLS CUI 2011AA)
255471002 (SNOMED CT 2011_0131)
C0234233 (UMLS CUI 2011AA)
247348008 (SNOMED CT 2011_0131)
10043224 (MedDRA 14.1)
Fever (see below) AND the incision (in case of post-surgical wound infections) is deliberately opened by a surgeon, unless the culture is negative
Item
Fever (see below) AND the incision (in case of post-surgical wound infections) is deliberately opened by a surgeon, unless the culture is negative
boolean
C0015967 (UMLS CUI 2011AA)
386661006 (SNOMED CT 2011_0131)
10005911 (MedDRA 14.1)
MTHU013518 (LOINC Version 232)
R50.9 (ICD-10-CM Version 2010)
780.60 (ICD-9-CM Version 2011)
E11102 (CTCAE 1105E)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0038941 (UMLS CUI 2011AA)
58126003 (SNOMED CT 2011_0131)
10036410 (MedDRA 14.1)
C0175566 (UMLS CUI 2011AA)
56116003 (SNOMED CT 2011_0131)
C0582175 (UMLS CUI 2011AA)
304292004 (SNOMED CT 2011_0131)
208600000X (HL7 V3 2006_05)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0855652 (UMLS CUI 2011AA)
10061448 (MedDRA 14.1)
Abscess or other evidence of infection involving the deep incision/trauma, found on direct examination, during reoperation/operation (in case of trauma), or by histologic or radiologic examination
Item
Abscess or other evidence of infection involving the deep incision/trauma, found on direct examination, during reoperation/operation (in case of trauma), or by histologic or radiologic examination
boolean
C0000833 (UMLS CUI 2011AA)
128477000 (SNOMED CT 2011_0131)
10000269 (MedDRA 14.1)
MTHU022414 (LOINC Version 232)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0205125 (UMLS CUI 2011AA)
795002 (SNOMED CT 2011_0131)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0439851 (UMLS CUI 2011AA)
255589003 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0038895 (UMLS CUI 2011AA)
C0035110 (UMLS CUI 2011AA)
261554009 (SNOMED CT 2011_0131)
10042618 (MedDRA 14.1)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0019637 (UMLS CUI 2011AA)
C1962945 (UMLS CUI 2011AA)
363680008 (SNOMED CT 2011_0131)
10048064 (MedDRA 14.1)
Diagnosis of a deep incisional/post-trauma Skin Structure Infections (SSI) by a surgeon or attending physician
Item
Diagnosis of a deep incisional/post-trauma Skin Structure Infections (SSI) by a surgeon or attending physician
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205125 (UMLS CUI 2011AA)
795002 (SNOMED CT 2011_0131)
C0184898 (UMLS CUI 2011AA)
34896006 (SNOMED CT 2011_0131)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C0175677 (UMLS CUI 2011AA)
417746004 (SNOMED CT 2011_0131)
10022116 (MedDRA 14.1)
T14.9 (ICD-10-CM Version 2010)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
C0582175 (UMLS CUI 2011AA)
304292004 (SNOMED CT 2011_0131)
208600000X (HL7 V3 2006_05)
C1320929 (UMLS CUI 2011AA)
405279007 (SNOMED CT 2011_0131)
ATTPHYS (HL7 V3 2006_05)
Bite wounds/clenched fist infections and wounds associated with injection drug abuse must meet the criteria defining a Complicated Skin and Skin Structure Infections (cSSSI)
Item
Bite wounds/clenched fist infections and wounds associated with injection drug abuse must meet the criteria defining a Complicated Skin and Skin Structure Infections (cSSSI)
boolean
C1827959 (UMLS CUI 2011AA)
424685008 (SNOMED CT 2011_0131)
C0043241 (UMLS CUI 2011AA)
76844004 (SNOMED CT 2011_0131)
10048038 (MedDRA 14.1)
MTHU020838 (LOINC Version 232)
E11635 (CTCAE 1105E)
C0043250 (UMLS CUI 2011AA)
13924000 (SNOMED CT 2011_0131)
10052428 (MedDRA 14.1)
MTHU001326 (LOINC Version 232)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
CL414621 (UMLS CUI 2011AA)
C1704788 (UMLS CUI 2011AA)
C0231242 (UMLS CUI 2011AA)
255302009 (SNOMED CT 2011_0131)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
Infected ischemic ulcers with at least one of the following conditions:
Item
Infected ischemic ulcers with at least one of the following conditions:
boolean
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0263555 (UMLS CUI 2011AA)
13954005 (SNOMED CT 2011_0131)
10059084 (MedDRA 14.1)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
Peripheral vascular disease
Item
Peripheral Vascular Diseases
boolean
C0085096 (UMLS CUI 2011AA)
400047006 (SNOMED CT 2011_0131)
10034636 (MedDRA 14.1)
MTHU020791 (LOINC Version 232)
I73.9 (ICD-10-CM Version 2010)
443.9 (ICD-9-CM Version 2011)
Conditions pre-disposing to pressure sores such as paraplegia, peripheral neuropathy
Item
Conditions pre-disposing to pressure sores such as paraplegia, peripheral neuropathy
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0012655 (UMLS CUI 2011AA)
76522002 (SNOMED CT 2011_0131)
C0011127 (UMLS CUI 2011AA)
399912005 (SNOMED CT 2011_0131)
10011985 (MedDRA 14.1)
MTHU021397 (LOINC Version 232)
L89 (ICD-10-CM Version 2010)
707.00 (ICD-9-CM Version 2011)
C0030486 (UMLS CUI 2011AA)
60389000 (SNOMED CT 2011_0131)
10033892 (MedDRA 14.1)
MTHU020806 (LOINC Version 232)
G82.20 (ICD-10-CM Version 2010)
344.1 (ICD-9-CM Version 2011)
C0031117 (UMLS CUI 2011AA)
10029331 (MedDRA 14.1)
G64 (ICD-10-CM Version 2010)
350-359.99 (ICD-9-CM Version 2011)
Presence of at least 3 of the following signs or symptoms:
Item
Presence of at least 3 of the following signs or symptoms:
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0220912 (UMLS CUI 2011AA)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
Purulent drainage or discharge
Item
Purulent drainage or discharge
boolean
C0439665 (UMLS CUI 2011AA)
255316004 (SNOMED CT 2011_0131)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
C0333274 (UMLS CUI 2011AA)
35013009 (SNOMED CT 2011_0131)
10037569 (MedDRA 14.1)
Erythema extending > 1 cm from the wound edge
Item
Erythema extending > 1 cm from the wound edge
boolean
C0041834 (UMLS CUI 2011AA)
70819003 (SNOMED CT 2011_0131)
10015150 (MedDRA 14.1)
L53.9 (ICD-10-CM Version 2010)
695.9 (ICD-9-CM Version 2011)
C0439792 (UMLS CUI 2011AA)
260858005 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0475210 (UMLS CUI 2011AA)
258672001 (SNOMED CT 2011_0131)
C0043250 (UMLS CUI 2011AA)
13924000 (SNOMED CT 2011_0131)
10052428 (MedDRA 14.1)
MTHU001326 (LOINC Version 232)
C0205154 (UMLS CUI 2011AA)
57183005 (SNOMED CT 2011_0131)
Fluctuance
Item
Fluctuance
boolean
C0949036 (UMLS CUI 2011AA)
10051723 (MedDRA 14.1)
Pain or tenderness to palpation
Item
Pain or tenderness to palpation
boolean
C0030193 (UMLS CUI 2011AA)
22253000 (SNOMED CT 2011_0131)
10033371 (MedDRA 14.1)
MTHU029813 (LOINC Version 232)
R52 (ICD-10-CM Version 2010)
338-338.9 (ICD-9-CM Version 2011)
E11167 (CTCAE 1105E)
C0234233 (UMLS CUI 2011AA)
247348008 (SNOMED CT 2011_0131)
10043224 (MedDRA 14.1)
C0030247 (UMLS CUI 2011AA)
113011001 (SNOMED CT 2011_0131)
Swelling or induration
Item
Swelling or induration
boolean
C0038999 (UMLS CUI 2011AA)
442672001 (SNOMED CT 2011_0131)
10042674 (MedDRA 14.1)
C0332534 (UMLS CUI 2011AA)
45147008 (SNOMED CT 2011_0131)
10060708 (MedDRA 14.1)
Fever, defined as body temperature
Item
Fever, defined as body temperature
boolean
C0015967 (UMLS CUI 2011AA)
386661006 (SNOMED CT 2011_0131)
10005911 (MedDRA 14.1)
MTHU013518 (LOINC Version 232)
R50.9 (ICD-10-CM Version 2010)
780.60 (ICD-9-CM Version 2011)
E11102 (CTCAE 1105E)
C1704788 (UMLS CUI 2011AA)
C0005903 (UMLS CUI 2011AA)
386725007 (SNOMED CT 2011_0131)
MTHU001362 (LOINC Version 232)
> 37.5°C (axillary)
Item
> 37.5°C (axillary)
boolean
C0439237 (UMLS CUI 2011AA)
258710007 (SNOMED CT 2011_0131)
CEL (HL7 V3 2006_05)
CL317948 (UMLS CUI 2011AA)
> 38°C (orally)
Item
> 38°C (orally)
boolean
C0439237 (UMLS CUI 2011AA)
258710007 (SNOMED CT 2011_0131)
CEL (HL7 V3 2006_05)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
> 38.5°C (tympanically) or
Item
> 38.5°C (tympanically) or
boolean
C0439237 (UMLS CUI 2011AA)
258710007 (SNOMED CT 2011_0131)
CEL (HL7 V3 2006_05)
C0041445 (UMLS CUI 2011AA)
42859004 (SNOMED CT 2011_0131)
MTHU014731 (LOINC Version 232)
> 39°C (rectally)
Item
> 39°C (rectally)
boolean
C0439237 (UMLS CUI 2011AA)
258710007 (SNOMED CT 2011_0131)
CEL (HL7 V3 2006_05)
C0205052 (UMLS CUI 2011AA)
255582007 (SNOMED CT 2011_0131)
OR
Item
Or
boolean
CL414906 (UMLS CUI 2011AA)
Elevated total peripheral white blood cell (WBC) count > 12,000/mm3 or
Item
Elevated total peripheral white blood cell (WBC) count > 12,000/mm3 or
boolean
CL414623 (UMLS CUI 2011AA)
C0205100 (UMLS CUI 2011AA)
14414005 (SNOMED CT 2011_0131)
C1271681 (UMLS CUI 2011AA)
391558003 (SNOMED CT 2011_0131)
10060297 (MedDRA 14.1)
>15 % immature neutrophils (bands) regardless of total peripheral WBC count
Item
>15 % immature neutrophils (bands) regardless of total peripheral WBC count
boolean
CL429329 (UMLS CUI 2011AA)
C0432611 (UMLS CUI 2011AA)
259712009 (SNOMED CT 2011_0131)
C1554079 (UMLS CUI 2011AA)
I (HL7 V3 2006_05)
C0205100 (UMLS CUI 2011AA)
14414005 (SNOMED CT 2011_0131)
C1271681 (UMLS CUI 2011AA)
391558003 (SNOMED CT 2011_0131)
10060297 (MedDRA 14.1)
C reactive protein (CRP) >20 mg/L
Item
C-Reactive Protein Measurement
boolean
C0201657 (UMLS CUI 2011AA)
55235003 (SNOMED CT 2011_0131)
10006824 (MedDRA 14.1)
Specimen obtained for culture from infected area by needle aspiration of obviously purulent material or by tissue biopsy or by curettage of the surface of ulcer within 48 hours prior to the initiation of study drug therapy
Item
Specimen obtained for culture from infected area by needle aspiration of obviously purulent material or by tissue biopsy or by curettage of the surface of ulcer within 48 hours prior to the initiation of study drug therapy
boolean
C0370003 (UMLS CUI 2011AA)
123038009 (SNOMED CT 2011_0131)
MTHU010726 (LOINC Version 232)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C0430400 (UMLS CUI 2011AA)
252398009 (SNOMED CT 2011_0131)
10061447 (MedDRA 14.1)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
CL419348 (UMLS CUI 2011AA)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0439665 (UMLS CUI 2011AA)
255316004 (SNOMED CT 2011_0131)
C0520510 (UMLS CUI 2011AA)
260769002 (SNOMED CT 2011_0131)
MTHU013790 (LOINC Version 232)
MAT (HL7 V3 2006_05)
C0040300 (UMLS CUI 2011AA)
85756007 (SNOMED CT 2011_0131)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
C0010468 (UMLS CUI 2011AA)
68688001 (SNOMED CT 2011_0131)
C0205148 (UMLS CUI 2011AA)
410679008 (SNOMED CT 2011_0131)
MTHU014970 (LOINC Version 232)
C0041582 (UMLS CUI 2011AA)
10045285 (SNOMED CT 2011_0131)
10045285 (MedDRA 14.1)
MTHU022920 (LOINC Version 232)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1704686 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
CL428482 (UMLS CUI 2011AA)
Duration of treatment of the skin/skin structure infection is anticipated to be at least 7 days.
Item
Duration of treatment of the skin/skin structure infection is anticipated to be at least 7 days.
boolean
C0444917 (UMLS CUI 2011AA)
261773006 (SNOMED CT 2011_0131)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
C0679106 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205453 (UMLS CUI 2011AA)
65607009 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
Surgical drainage or debridement of infected wounds or abscesses, if necessary, have to have been completed <= 48 hours after the initiation of study drug therapy
Item
Surgical drainage or debridement of infected wounds or abscesses, if necessary, have to have been completed <= 48 hours after the initiation of study drug therapy
boolean
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0013103 (UMLS CUI 2011AA)
122462000 (SNOMED CT 2011_0131)
C0011079 (UMLS CUI 2011AA)
36777000 (SNOMED CT 2011_0131)
10067806 (MedDRA 14.1)
C0043241 (UMLS CUI 2011AA)
76844004 (SNOMED CT 2011_0131)
10048038 (MedDRA 14.1)
MTHU020838 (LOINC Version 232)
E11635 (CTCAE 1105E)
C0000833 (UMLS CUI 2011AA)
128477000 (SNOMED CT 2011_0131)
10000269 (MedDRA 14.1)
MTHU022414 (LOINC Version 232)
C0750557 (UMLS CUI 2011AA)
C1555447 (UMLS CUI 2011AA)
MEDNEC (HL7 V3 2006_05)
C1556116 (UMLS CUI 2011AA)
completed (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C1704686 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
CL428482 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Women, who are pregnant or lactating, or in whom pregnancy can not be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before randomization to the study drug)
Item
Women, who are pregnant or lactating, or in whom pregnancy can not be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before randomization to the study drug)
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C1518422 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
C0430056 (UMLS CUI 2011AA)
167252002 (SNOMED CT 2011_0131)
10036576 (MedDRA 14.1)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0444868 (UMLS CUI 2011AA)
261675009 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
The following skin and skin structure infections:
Item
The following skin and skin structure infections:
boolean
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
Necrotizing fasciitis including Fourniers gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis
Item
Necrotizing fasciitis including Fourniers gangrene, ecthyma gangrenosum, streptococcal necrotizing fasciitis and clostridial necrotizing fasciitis
boolean
C0238124 (UMLS CUI 2011AA)
52486002 (SNOMED CT 2011_0131)
10028885 (MedDRA 14.1)
M72.6 (ICD-10-CM Version 2010)
728.86 (ICD-9-CM Version 2011)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0238419 (UMLS CUI 2011AA)
398318005 (SNOMED CT 2011_0131)
10017068 (MedDRA 14.1)
N49.3 (ICD-10-CM Version 2010)
C0276085 (UMLS CUI 2011AA)
17732003 (SNOMED CT 2011_0131)
10069756 (MedDRA 14.1)
C0854084 (UMLS CUI 2011AA)
10028888 (MedDRA 14.1)
C1622996 (UMLS CUI 2011AA)
413861006 (SNOMED CT 2011_0131)
C0238124 (UMLS CUI 2011AA)
52486002 (SNOMED CT 2011_0131)
10028885 (MedDRA 14.1)
M72.6 (ICD-10-CM Version 2010)
728.86 (ICD-9-CM Version 2011)
Burn wound infections
Item
Burn wound infections
boolean
C0006434 (UMLS CUI 2011AA)
48333001 (SNOMED CT 2011_0131)
10006634 (MedDRA 14.1)
MTHU007829 (LOINC Version 232)
T30.0 (ICD-10-CM Version 2010)
949.0 (ICD-9-CM Version 2011)
E11669 (CTCAE 1105E)
C0043241 (UMLS CUI 2011AA)
76844004 (SNOMED CT 2011_0131)
10048038 (MedDRA 14.1)
MTHU020838 (LOINC Version 232)
E11635 (CTCAE 1105E)
Secondary infections of a chronic skin disease (e.g. atopic dermatitis)
Item
Secondary infections of a chronic skin disease (e.g. atopic dermatitis)
boolean
C0442886 (UMLS CUI 2011AA)
264569006 (SNOMED CT 2011_0131)
10062158 (MedDRA 14.1)
C1290009 (UMLS CUI 2011AA)
128236002 (SNOMED CT 2011_0131)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
Infection of prosthetic materials (e.g. subcutaneous tissue infection related to a central venous catheter or permanent cardiac pacemaker battery pack). Subjects with removal of a prosthetic device involved in an infection should not be included
Item
Infection of prosthetic materials (e.g. subcutaneous tissue infection related to a central venous catheter or permanent cardiac pacemaker battery pack). Subjects with removal of a prosthetic device involved in an infection should not be included
boolean
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0444752 (UMLS CUI 2011AA)
261389007 (SNOMED CT 2011_0131)
C0278403 (UMLS CUI 2011AA)
71966008 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
C1145640 (UMLS CUI 2011AA)
52124006 (SNOMED CT 2011_0131)
C1828453 (UMLS CUI 2011AA)
424921004 (SNOMED CT 2011_0131)
CL381593 (UMLS CUI 2011AA)
CL425201 (UMLS CUI 2011AA)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0175649 (UMLS CUI 2011AA)
53350007 (SNOMED CT 2011_0131)
C0699733 (UMLS CUI 2011AA)
49062001 (SNOMED CT 2011_0131)
MTHU020022 (LOINC Version 232)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Infections where a surgical procedure alone is definitive therapy
Item
Infections where a surgical procedure alone is definitive therapy
boolean
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0038895 (UMLS CUI 2011AA)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
CL426229 (UMLS CUI 2011AA)
Subjects with uncomplicated skin and skin structure infections including folliculitis and furunculosis, carbunculosis, simple abscesses and superficial cellulitis
Item
Subjects with uncomplicated skin and skin structure infections including folliculitis and furunculosis, carbunculosis, simple abscesses and superficial cellulitis
boolean
C0443334 (UMLS CUI 2011AA)
263914008 (SNOMED CT 2011_0131)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0016436 (UMLS CUI 2011AA)
13600006 (SNOMED CT 2011_0131)
10016936 (MedDRA 14.1)
C0016867 (UMLS CUI 2011AA)
112650006 (SNOMED CT 2011_0131)
10017557 (MedDRA 14.1)
L02.92 (ICD-10-CM Version 2010)
C0007078 (UMLS CUI 2011AA)
41570003 (SNOMED CT 2011_0131)
10007247 (MedDRA 14.1)
C0205352 (UMLS CUI 2011AA)
13673007 (SNOMED CT 2011_0131)
C0000833 (UMLS CUI 2011AA)
128477000 (SNOMED CT 2011_0131)
10000269 (MedDRA 14.1)
MTHU022414 (LOINC Version 232)
C0205124 (UMLS CUI 2011AA)
26283006 (SNOMED CT 2011_0131)
C0007642 (UMLS CUI 2011AA)
128045006 (SNOMED CT 2011_0131)
10007882 (MedDRA 14.1)
L03.90 (ICD-10-CM Version 2010)
Known hypersensitivity to quinolones and/or any type of beta-lactam antibiotic drugs or any of the excipients
Item
Known hypersensitivity to quinolones and/or any type of beta-lactam antibiotic drugs or any of the excipients
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0034428 (UMLS CUI 2011AA)
CL407060 (UMLS CUI 2011AA)
C0332307 (UMLS CUI 2011AA)
410657003 (SNOMED CT 2011_0131)
MTHU013727 (LOINC Version 232)
C0026458 (UMLS CUI 2011AA)
90614001 (SNOMED CT 2011_0131)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin-clavulanic acid
Item
Previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin-clavulanic acid
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0268317 (UMLS CUI 2011AA)
75066002 (SNOMED CT 2011_0131)
C0920027 (UMLS CUI 2011AA)
10050279 (MedDRA 14.1)
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
CL414314 (UMLS CUI 2011AA)
89519005 (SNOMED CT 2011_0131)
MTHU006777 (LOINC Version 232)
Severe, life threatening disease with a life expectancy of < 2 months
Item
Severe, life threatening disease with a life expectancy of < 2 months
boolean
C2711184 (UMLS CUI 2011AA)
442452003 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0547044 (UMLS CUI 2011AA)
263796003 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Immunosuppression including:
Item
Immunosuppression including:
boolean
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
Known neutropenia (neutrophil count < 1000/µL)
Item
Known neutropenia (neutrophil count < 1000/µL)
boolean
C0853697 (UMLS CUI 2011AA)
10029366 (MedDRA 14.1)
E12198 (CTCAE 1105E)
C0200633 (UMLS CUI 2011AA)
30630007 (SNOMED CT 2011_0131)
10029363 (MedDRA 14.1)
Known lymphopenia with absolute CD4+ T cell count < 200/mm3
Item
Known lymphopenia with absolute CD4+ T cell count < 200/mm3
boolean
C0024312 (UMLS CUI 2011AA)
48813009 (SNOMED CT 2011_0131)
10025327 (MedDRA 14.1)
D72.810 (ICD-10-CM Version 2010)
288.51 (ICD-9-CM Version 2011)
E12190 (CTCAE 1105E)
C0243009 (UMLS CUI 2011AA)
MTHU112269 (CTCAE 1105E)
Acquired immunodeficiency syndrome (AIDS)-defining event and/or concomitant therapy with Highly Active Antiretroviral Therapy (HAART)
Item
Acquired immunodeficiency syndrome (AIDS)-defining event and/or concomitant therapy with Highly Active Antiretroviral Therapy (HAART)
boolean
C0001175 (UMLS CUI 2011AA)
62479008 (SNOMED CT 2011_0131)
10000565 (MedDRA 14.1)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
C1704788 (UMLS CUI 2011AA)
C0441471 (UMLS CUI 2011AA)
272379006 (SNOMED CT 2011_0131)
MTHU019184 (LOINC Version 232)
C1707479 (UMLS CUI 2011AA)
C0887947 (UMLS CUI 2011AA)
416234007 (SNOMED CT 2011_0131)
Chronic treatment (>/= 2 weeks) with known immunosuppressant therapy (including treatment with > 15 mg/day of systemic prednisone or equivalent)
Item
Chronic treatment (>/= 2 weeks) with known immunosuppressant therapy (including treatment with > 15 mg/day of systemic prednisone or equivalent)
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
Any other congenital or acquired immune defect or immunosuppression
Item
Any other congenital or acquired immune defect or immunosuppression
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0009678 (UMLS CUI 2011AA)
C0439661 (UMLS CUI 2011AA)
255396000 (SNOMED CT 2011_0131)
C0021053 (UMLS CUI 2011AA)
71922006 (SNOMED CT 2011_0131)
10021425 (MedDRA 14.1)
D89.9 (ICD-10-CM Version 2010)
279.9 (ICD-9-CM Version 2011)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
Known severe hepatic insufficiency (Child Pugh C) or transaminases increase > 5 fold upper limit of normal (ULN)
Item
Known severe hepatic insufficiency (Child Pugh C) or transaminases increase > 5 fold upper limit of normal (ULN)
boolean
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1306571 (UMLS CUI 2011AA)
59927004 (SNOMED CT 2011_0131)
10056542 (MedDRA 14.1)
C2347612 (UMLS CUI 2011AA)
C0439106 (UMLS CUI 2011AA)
257962003 (SNOMED CT 2011_0131)
C0438717 (UMLS CUI 2011AA)
10054889 (MedDRA 14.1)
CL384738 (UMLS CUI 2011AA)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C1632851 (UMLS CUI 2011AA)
417929005 (SNOMED CT 2011_0131)
C1519815 (UMLS CUI 2011AA)
Known renal impairment with a baseline measured or calculated serum creatinine clearance < 40 mL/min
Item
Known renal impairment with a baseline measured or calculated serum creatinine clearance < 40 mL/min
boolean
C0341697 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
C1442488 (UMLS CUI 2011AA)
C0444706 (UMLS CUI 2011AA)
258104002 (SNOMED CT 2011_0131)
C0444686 (UMLS CUI 2011AA)
258090004 (SNOMED CT 2011_0131)
C0373595 (UMLS CUI 2011AA)
167181009 (SNOMED CT 2011_0131)
10011371 (MedDRA 14.1)
Known prolongation of the QT interval or concomitant use of drugs reported to increase the QT interval (e.g. Class IA or Class III antiarrhythmics [eg., quinidine, procainamide, amiodarone, sotalol], neuroleptics [e.g. haloperidol], tricyclic antidepressive agents, certain antimicrobials [e.g. pentamidine, halofantrine], certain antihistaminics [e.g. terfenadine], and other [cisapride, vincamine IV, depridil, diphemanil])
Item
Known prolongation of the QT interval or concomitant use of drugs reported to increase the QT interval (e.g. Class IA or Class III antiarrhythmics [eg., quinidine, procainamide, amiodarone, sotalol], neuroleptics [e.g. haloperidol], tricyclic antidepressive agents, certain antimicrobials [e.g. pentamidine, halofantrine], certain antihistaminics [e.g. terfenadine], and other [cisapride, vincamine IV, depridil, diphemanil])
boolean
C0151878 (UMLS CUI 2011AA)
111975006 (SNOMED CT 2011_0131)
10014387 (MedDRA 14.1)
E12146 (CTCAE 1105E)
C2347852 (UMLS CUI 2011AA)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
C1287082 (UMLS CUI 2011AA)
365417009 (SNOMED CT 2011_0131)
C1579436 (UMLS CUI 2011AA)
C0360703 (UMLS CUI 2011AA)
372855004 (SNOMED CT 2011_0131)
C0034414 (UMLS CUI 2011AA)
372697008 (SNOMED CT 2011_0131)
MTHU005039 (LOINC Version 232)
C0033216 (UMLS CUI 2011AA)
372589008 (SNOMED CT 2011_0131)
MTHU005035 (LOINC Version 232)
C0002598 (UMLS CUI 2011AA)
372821002 (SNOMED CT 2011_0131)
MTHU004841 (LOINC Version 232)
C0037707 (UMLS CUI 2011AA)
372911006 (SNOMED CT 2011_0131)
MTHU003385 (LOINC Version 232)
C0040615 (UMLS CUI 2011AA)
10784006, 372482001 (SNOMED CT 2011_0131)
MTHU003337 (LOINC Version 232)
C0018546 (UMLS CUI 2011AA)
386837002 (SNOMED CT 2011_0131)
MTHU005005 (LOINC Version 232)
C0003290 (UMLS CUI 2011AA)
373253007 (SNOMED CT 2011_0131)
MTHU001920 (LOINC Version 232)
C1136254 (UMLS CUI 2011AA)
250428009 (SNOMED CT 2011_0131)
MTHU014499 (LOINC Version 232)
C0030863 (UMLS CUI 2011AA)
372699006 (SNOMED CT 2011_0131)
C0120726 (UMLS CUI 2011AA)
372527008 (SNOMED CT 2011_0131)
C0003360 (UMLS CUI 2011AA)
372806008 (SNOMED CT 2011_0131)
MTHU003328 (LOINC Version 232)
C0085173 (UMLS CUI 2011AA)
387089004 (SNOMED CT 2011_0131)
MTHU003387 (LOINC Version 232)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0072916 (UMLS CUI 2011AA)
387164008 (SNOMED CT 2011_0131)
MTHU012783 (LOINC Version 232)
C0042674 (UMLS CUI 2011AA)
C0677510 (UMLS CUI 2011AA)
260317009 (SNOMED CT 2011_0131)
C0301371 (UMLS CUI 2011AA)
373748003 (SNOMED CT 2011_0131)
Uncorrected hypokalemia
Item
Uncorrected hypokalemia
boolean
C1518422 (UMLS CUI 2011AA)
C1947976 (UMLS CUI 2011AA)
C0020621 (UMLS CUI 2011AA)
43339004 (SNOMED CT 2011_0131)
10021015 (MedDRA 14.1)
E87.6 (ICD-10-CM Version 2010)
276.8 (ICD-9-CM Version 2011)
E12327 (CTCAE 1105E)
Clinically relevant bradycardia
Item
Clinically relevant bradycardia
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0428977 (UMLS CUI 2011AA)
48867003 (SNOMED CT 2011_0131)
10006093 (MedDRA 14.1)
R00.1 (ICD-10-CM Version 2010)
Clinically relevant heart failure with reduced left ventricular ejection fraction (i.e., below 40%)
Item
Clinically relevant heart failure with reduced left ventricular ejection fraction (i.e., below 40%)
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C1096403 (UMLS CUI 2011AA)
10053222 (MedDRA 14.1)
CL384716 (UMLS CUI 2011AA)
Previous history of symptomatic arrhythmias
Item
Previous history of symptomatic arrhythmias
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0231220 (UMLS CUI 2011AA)
264931009 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
Previous history of tendon disease/disorder with quinolones
Item
Previous history of tendon disease/disorder with quinolones
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0151936 (UMLS CUI 2011AA)
68172002 (SNOMED CT 2011_0131)
10043239 (MedDRA 14.1)
C0034428 (UMLS CUI 2011AA)
Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment, e.g. underlying septic arthritis
Item
Known or suspected concomitant bacterial infection requiring additional systemic antibacterial treatment, e.g. underlying septic arthritis
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
CL415222 (UMLS CUI 2011AA)
C0004623 (UMLS CUI 2011AA)
87628006 (SNOMED CT 2011_0131)
10060945 (MedDRA 14.1)
A49.9 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0854606 (UMLS CUI 2011AA)
10042933 (MedDRA 14.1)
C1692886 (UMLS CUI 2011AA)
372938004 (SNOMED CT 2011_0131)
10053555 (MedDRA 14.1)
M00.9 (ICD-10-CM Version 2010)
711.0 (ICD-9-CM Version 2011)
Requiring therapy with probenecid
Item
Requiring therapy with probenecid
boolean
C1514873 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0033209 (UMLS CUI 2011AA)
387365004 (SNOMED CT 2011_0131)
MTHU007603 (LOINC Version 232)
Treatment with a systemic or topical antibacterial agent for > 24 hours in the previous 7 days preceding study entry unless the subject showed no response or had worsening of clinical signs and symptoms despite 3 or more days of prior therapy and a culture obtained at the time of subject enrollment showed persistence of a pathogen which is susceptible to the study drugs. The prior antimicrobial therapy must not have been a fluoroquinolone or a beta lactam/beta lactamase combination
Item
Treatment with a systemic or topical antibacterial agent for > 24 hours in the previous 7 days preceding study entry unless the subject showed no response or had worsening of clinical signs and symptoms despite 3 or more days of prior therapy and a culture obtained at the time of subject enrollment showed persistence of a pathogen which is susceptible to the study drugs. The prior antimicrobial therapy must not have been a fluoroquinolone or a beta lactam/beta lactamase combination
boolean
C0039798 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C1522168 (UMLS CUI 2011AA)
6064005 (SNOMED CT 2011_0131)
TOPICAL (HL7 V3 2006_05)
C0279516 (UMLS CUI 2011AA)
419241000 (SNOMED CT 2011_0131)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0205453 (UMLS CUI 2011AA)
65607009 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0438286 (UMLS CUI 2011AA)
266721009 (SNOMED CT 2011_0131)
10063670 (MedDRA 14.1)
C0332271 (UMLS CUI 2011AA)
230993007 (SNOMED CT 2011_0131)
C0037088 (UMLS CUI 2011AA)
404684003 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C1514463 (UMLS CUI 2011AA)
C0430400 (UMLS CUI 2011AA)
252398009 (SNOMED CT 2011_0131)
10061447 (MedDRA 14.1)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0546816 (UMLS CUI 2011AA)
130965009 (SNOMED CT 2011_0131)
C0450254 (UMLS CUI 2011AA)
264418008 (SNOMED CT 2011_0131)
C0231204 (UMLS CUI 2011AA)
131196009 (SNOMED CT 2011_0131)
S (HL7 V3 2006_05)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
C1136254 (UMLS CUI 2011AA)
250428009 (SNOMED CT 2011_0131)
MTHU014499 (LOINC Version 232)
C1518422 (UMLS CUI 2011AA)
C0949665 (UMLS CUI 2011AA)
C1947911 (UMLS CUI 2011AA)
C0282215 (UMLS CUI 2011AA)
406778007 (SNOMED CT 2011_0131)
C0597979 (UMLS CUI 2011AA)
79744009 (SNOMED CT 2011_0131)
Infection known to be due to a Methicillin-Resistant Staphylococcus Aureus (MRSA), Methicillin-Resistant Staphylococcus Epidermidis (MRSE) or Vancomycin Resistant Enterococcus (VRE) as the single isolated pathogen
Item
Infection known to be due to a Methicillin-Resistant Staphylococcus Aureus (MRSA), Methicillin-Resistant Staphylococcus Epidermidis (MRSE) or Vancomycin Resistant Enterococcus (VRE) as the single isolated pathogen
boolean
C0343401 (UMLS CUI 2011AA)
266096002 (SNOMED CT 2011_0131)
10027508 (MedDRA 14.1)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
CL420107 (UMLS CUI 2011AA)
C1955827 (UMLS CUI 2011AA)
C0038174 (UMLS CUI 2011AA)
60875001 (SNOMED CT 2011_0131)
C1265175 (UMLS CUI 2011AA)
113727004 (SNOMED CT 2011_0131)
C0205171 (UMLS CUI 2011AA)
50607009 (SNOMED CT 2011_0131)
C0205409 (UMLS CUI 2011AA)
46651001 (SNOMED CT 2011_0131)
C0450254 (UMLS CUI 2011AA)
264418008 (SNOMED CT 2011_0131)
Previous enrolment in this study
Item
Previous enrolment in this study
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Participation in any clinical investigational drug study within 4 weeks of screening
Item
Participation in any clinical investigational drug study within 4 weeks of screening
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1409616 (UMLS CUI 2011AA)
Previous history of seizure disorders
Item
Previous history of seizure disorders
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0014544 (UMLS CUI 2011AA)
84757009 (SNOMED CT 2011_0131)
10015037 (MedDRA 14.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)