Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Eligibility criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Informed consent
Item
1. Signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Medical history Hypereosinophilic Syndrome
Item
2. Subjects with documented history of HES.
boolean
C0262926 (UMLS CUI [1,1])
C1540912 (UMLS CUI [1,2])
prednisone treatment
Item
3. Subjects must achieve and maintain a stable prednisone monotherapy status prior to randomization.
boolean
C0747791 (UMLS CUI [1])
Protocol completion
Item
4. Subjects must complete all the screening/baseline assessments as outlined in the protocol.
boolean
C2826674 (UMLS CUI [1])
Gender; Age; Pregnancy; Childbearing Potential; Contraceptive methods
Item
5. Male or female, 18-75 years of age. A female subject is eligible to enter the study if she is: • Not pregnant or nursing • Of non-childbearing potential (i.e., women who had a hysterectomy, are post-menopausal which is defined as 1 year without menses, have both ovaries surgically removed, or have current documented tubule ligation); or • Of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at the Screening Visit, and agree to one of the following: 1). Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of investigational product until 3 months after the last dose of investigational product; or 2). Consistent and correct use of one of the following acceptable methods of birth control for one month prior to the start of the investigation product and three months after the last dose: • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subjects; • Implants of levonorgestrel; • Injectable progestogen; • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; • Oral contraceptives (either combined or progestogen only) • Double-barrier methods including diaphragm or condom with a spermicide.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C3831118 (UMLS CUI [4])
C0700589 (UMLS CUI [5])
Comorbidity
Item
1. Subjects with life-threatening or other serious illness or clinical manifestation deemed inappropriate for inclusion in study per the principal investigator.
boolean
C0009488 (UMLS CUI [1])
Secondary eosinophilia drug eruption parasitic infection graft-versus host disease
Item
2. Known secondary causes of eosinophilia: drug eruption and parasitic infection occurring within a year prior to the Screening Visit, history of graft-versus host disease, bullous pemphigoid, cystic fibrosis, rheumatoid arthritis and human immunodeficiency virus (HIV) infection
boolean
C0272194 (UMLS CUI [1,1])
C0011609 (UMLS CUI [1,2])
C0747256 (UMLS CUI [1,3])
C0018133 (UMLS CUI [1,4])
Churg-Strauss Syndrome
Item
3. Known Churg-Strauss Syndrome
boolean
C0008728 (UMLS CUI [1])
Wegeners Granulomatosis
Item
4. Known Wegener's Granulomatosis
boolean
C3495801 (UMLS CUI [1])
medical history malignant Neoplasms; Therapy chemotherapy radiotherapy Interleukin-2 therapy
Item
5. Known lymphoma, hematological malignancy, advanced and metastatic solid tumors and/or subjects who are under chemotherapy, radiotherapy or interleukin 2 treatment
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C0199975 (UMLS CUI [2,4])
Serum creatinine; AST or/ALT; Platelet count
Item
6. Abnormal laboratory value of: • Serum creatinine ≥ 3 times institutional upper limit normal (ULN) • AST or/ALT ≥ 5 times institutional ULN • Platelet count < 50,000/ μ L
boolean
C0201976 (UMLS CUI [1])
C3831581 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Cardiac function LVEF NYHA class IIIb or IV Angina Pectoris acute myocardial infarction
Item
7. Cardiac function as the following: • Left ventricular ejection fraction (LVEF) < 20%. (Subject with a history of LVEF <20% within 6 months prior to screening should also be excluded). • NYHA class IIIb or IV • Angina or acute myocardial infarction
boolean
C0232164 (UMLS CUI [1,1])
C0428772 (UMLS CUI [1,2])
C0278962 (UMLS CUI [1,3])
C0002962 (UMLS CUI [1,4])
C0155626 (UMLS CUI [1,5])
Hypersensitivity antibody therapy
Item
8. Known history of allergic reaction to previous antibody therapy.
boolean
C0020517 (UMLS CUI [1,1])
C0281176 (UMLS CUI [1,2])
Therapy monoclonal antibody
Item
9. Prior treatment with an anti-hIL-5 monoclonal antibody.
boolean
C0087111 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
Investigational drug
Item
10. Use of an investigational drug within 30 days of entering the study (Screening Visit).
boolean
C0013230 (UMLS CUI [1])
Substance use disorder
Item
11. Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months.
boolean
C0038586 (UMLS CUI [1])
Positive serum pregnancy test
Item
12. Positive serum pregnancy test at the Screening Visit or urine pregnancy test at Baseline Visit.
boolean
C0430063 (UMLS CUI [1])
Fusion Gene Positive
Item
13. Test positive for FIP1L1-PDGFR α fusion gene.
boolean
C1533585 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])