Age
Item
is male or female ≥5 years old
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential | Perimenopausal state Menstrual period
Item
if female of childbearing potential (including perimenopausal women who have had a menstrual period within one year):
boolean
C3831118 (UMLS CUI [1])
C3839366 (UMLS CUI [2,1])
C0025329 (UMLS CUI [2,2])
Breast Feeding Absent
Item
1. not breastfeeding
boolean
C0006147 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Pregnancy test negative
Item
2. negative pregnancy test result
boolean
C0427780 (UMLS CUI [1])
Contraceptive methods | Contraceptive implant | Injectable contraception | Contraceptives, Oral | Intrauterine Devices | Sexual Abstinence | Tubal Ligation | Partner had vasectomy | Barrier Contraception Double | Vaginal contraceptive diaphragm | Condoms, Male | Spermatocidal Agents
Item
3. must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of the study (double barrier methods including the use of female diaphragm and male condom with spermicide can also be used.)
boolean
C0700589 (UMLS CUI [1])
C1657106 (UMLS CUI [2])
C1262153 (UMLS CUI [3])
C0009905 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0036899 (UMLS CUI [6])
C0520483 (UMLS CUI [7])
C0420842 (UMLS CUI [8])
C0004764 (UMLS CUI [9,1])
C0205173 (UMLS CUI [9,2])
C0042241 (UMLS CUI [10])
C0009653 (UMLS CUI [11])
C0037862 (UMLS CUI [12])
Lipodystrophy | Loss of body fat Generalized | Loss of body fat Partial
Item
has physician-confirmed lipodystrophy as defined by evidence of generalized (whole body) or partial (limbs) loss of body fat outside the range of normal variation
boolean
C0023787 (UMLS CUI [1])
C0424630 (UMLS CUI [2,1])
C0205246 (UMLS CUI [2,2])
C0424630 (UMLS CUI [3,1])
C0728938 (UMLS CUI [3,2])
Metabolic Disease Quantity
Item
has been diagnosed with at least one of the following 2 metabolic disorders:
boolean
C0025517 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Diabetes Mellitus
Item
1. diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Hypertriglyceridemia | Serum fasting triglyceride measurement
Item
2. hypertriglyceridemia as defined by fasting triglyceride concentrations >200 mg/dl
boolean
C0020557 (UMLS CUI [1])
C0582824 (UMLS CUI [2])
Age | Informed Consent | Protocol Compliance
Item
if ≥18 years of age, is able to read, understand, and sign the informed consent form (icf) and an authorization to use and disclose protected health information form, communicate with the investigator, and understand and comply with protocol requirements
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
Age | Informed Consent Parent | Informed Consent Guardian | Protocol Compliance Parent | Protocol Compliance Guardian
Item
if <18 years of age, has a parent or legal guardian to read and understand the icf and child assent form, communicate with the investigator, and understand and comply with protocol requirements. adolescent subjects must also read and understand the child assent form; if the child is too young or unable to read, then the child assent form must be explained to the child.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4,1])
C0030551 (UMLS CUI [4,2])
C0525058 (UMLS CUI [5,1])
C1274041 (UMLS CUI [5,2])
HIV Infection
Item
has been diagnosed with hiv infection
boolean
C0019693 (UMLS CUI [1])
Liver disorder due to infection
Item
has known infectious liver disease
boolean
C0400888 (UMLS CUI [1])
Hypersensitivity Escherichia coli Proteins | Hypersensitivity Component Investigational Therapy
Item
has known allergies to e. coli-derived proteins or hypersensitivity to any component of study treatment
boolean
C0020517 (UMLS CUI [1,1])
C0014834 (UMLS CUI [1,2])
C0033684 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0949266 (UMLS CUI [2,3])