Body Weight | Body mass index
Item
weighs at least 45 kg and body mass index of 18 to 40 kg/m2, inclusive
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
an estimated creatinine clearance value based on cockcroft-gault method of:
boolean
C2711451 (UMLS CUI [1])
Normal renal function
Item
>80 ml/min for subjects with normal renal function
boolean
C0232805 (UMLS CUI [1])
Renal Insufficiency Severe
Item
<30 ml/min for subjects with severe renal impairment
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Hemodialysis times per week | Renal Insufficiency End-stage
Item
receiving hemodialysis three times a week for subjects with end stage renal impairment
boolean
C0019004 (UMLS CUI [1,1])
C0456698 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0205088 (UMLS CUI [2,2])
Gender | Postmenopausal state | Female Sterilization | Contraceptive methods | Pregnancy Absent | Breast Feeding Absent
Item
if female, the subject is at least 2 years postmenopausal, surgically sterile or practicing effective birth control, and is not pregnant or lactating
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0032961 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0006147 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Venous access patent
Item
good venous access
boolean
C3164222 (UMLS CUI [1])
Illness Clinical Significance | Exception Kidney Disease | Exception Diabetes Mellitus Stable | Exception Hypertensive disease
Item
history of any clinically significant acute illness (other than renal disease and conditions related to the renal disease in renal impairment subjects, such as stable diabetes or hypertension)
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0022658 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0011849 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0020538 (UMLS CUI [4,2])
Kidney Transplantation
Item
has had a kidney transplant that is still functioning
boolean
C0022671 (UMLS CUI [1])
Syncope Unexplained | Cardiac Arrest | Cardiac Arrhythmia Unexplained | Torsades de Pointes | Structural disorder of heart | Prolonged QT interval | Family history of long QT syndrome
Item
history of unexplained syncope, cardiac arrest, unexplained cardiac arrythmia or torsade de pointes, structural heart disease, prolonged qt interval, or family history of long qt syndrome
boolean
C0039070 (UMLS CUI [1,1])
C4288071 (UMLS CUI [1,2])
C0018790 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C4288071 (UMLS CUI [3,2])
C0040479 (UMLS CUI [4])
C1290384 (UMLS CUI [5])
C0151878 (UMLS CUI [6])
C3839836 (UMLS CUI [7])
Hypersensitivity Telavancin | Hypersensitivity Telavancin Excipient | Allergic Reaction Severe | Anaphylaxis Severe
Item
known hypersensitivity to telavancin or any of the excipients in the formulation, or a history of severe allergic or anaphylactic reactions
boolean
C0020517 (UMLS CUI [1,1])
C1453642 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1453642 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0002792 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Alcohol consumption Alcoholic Beverages U/week | Alcoholic Intoxication, Chronic | Substance Use Disorders
Item
history of consuming more than 7 units of alcoholic beverages per week, or history of alcoholism or substance abuse within past 2 years
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0560588 (UMLS CUI [1,3])
C0001973 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
HIV Seropositivity
Item
known to be positive for human immunodeficiency virus antibody
boolean
C0019699 (UMLS CUI [1])
Normal renal function | Pharmacotherapy | Prescription Drugs | Drugs, Non-Prescription | Complementary and alternative medicine | Exception Oral Contraceptives | Exception Hormone replacement therapy | Exception Aspirin Daily | Exception Acetaminophen Occasional
Item
for subjects with normal renal function, has had treatment with prescription or non-prescription drugs, including complementary and alternative medicines or over-the counter medications, with the exception of oral contraceptives, hormone replacement therapy, daily aspirin, and occasional use of acetaminophen within the past 14 days
boolean
C0232805 (UMLS CUI [1])
C0013216 (UMLS CUI [2])
C0304227 (UMLS CUI [3])
C0013231 (UMLS CUI [4])
C1148475 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0009905 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0282402 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0004057 (UMLS CUI [8,2])
C0332173 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0000970 (UMLS CUI [9,2])
C0521114 (UMLS CUI [9,3])
Renal Insufficiency | Absence Pharmaceutical Preparations Stable | Pharmaceutical Preparations Interfere Evaluation Telavancin
Item
for subjects with renal impairment, has not been on a stable dose of concomitant medications for at least 2 weeks prior to study start or is taking any medication that would interfere with the evaluation of televancin in this study
boolean
C1565489 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C1453642 (UMLS CUI [3,4])
Investigational New Drugs
Item
has received an experimental agent within 30 days or ten half-lives, whichever is longer, prior to study drug administration
boolean
C0013230 (UMLS CUI [1])
Blood Loss Significant | Blood Donation Amount | Blood Transfusion Received | Plasma donation
Item
has had any significant blood loss, donated one unit (450 ml) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to admission
boolean
C3163616 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0005794 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0005841 (UMLS CUI [3,1])
C1514756 (UMLS CUI [3,2])
C0032105 (UMLS CUI [4,1])
C0680854 (UMLS CUI [4,2])