Clinical Trial Preceding Completed | ABT-122 | Discontinuation Criteria Absent
Item
1. subjects who have completed the preceding study m12-963 (abt-122) rct study and have not developed any discontinuation criteria, as defined in section 5.4.1 of study m12-963.
boolean
C0008976 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C4547412 (UMLS CUI [2])
C1444662 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Gender
Item
2. if female, subject must meet one of the following criteria:
boolean
C0079399 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal (defined as no menses for at least 1 year).
boolean
C0232970 (UMLS CUI [1])
Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy
Item
surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
boolean
C0015787 (UMLS CUI [1])
C0589114 (UMLS CUI [2])
C0278321 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
Contraceptive methods | Tubal Ligation Requirement Contraceptive method second
Item
practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug. females who have undergone tubal ligation will be required to agree to use a second form of contraception for the same period of time.
boolean
C0700589 (UMLS CUI [1])
C0520483 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0205436 (UMLS CUI [2,4])
Gender Contraceptive methods | Omission Sperm donation
Item
3. male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3845736 (UMLS CUI [2,1])
C0871414 (UMLS CUI [2,2])
Informed Consent
Item
4. subjects must voluntarily sign and date an informed consent, approved by an independent ethics committee (iec)/institutional review board (irb), prior to the initiation of any screening or study-specific procedures.
boolean
C0021430 (UMLS CUI [1])
Good health Medical History | Good health Physical Examination | Good health Laboratory Procedures
Item
5. subject is judged to be in good health as determined by the investigator based on the results of medical history, physical examination and laboratory profile performed.
boolean
C3813622 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3813622 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C3813622 (UMLS CUI [3,1])
C0022885 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
1. pregnant or breastfeeding female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Communicable Diseases | Therapy Unsuccessful
Item
2. ongoing infections at day 1 (week 0) that have not been successfully treated within 14 days.
boolean
C0009450 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Requirement Anticipated Live Vaccine | Live Vaccine
Item
3. anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug.
boolean
C1514873 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C0042211 (UMLS CUI [1,3])
C0042211 (UMLS CUI [2])
Study Subject Participation Status | Clinical study | Exception Clinical Trial Specified
Item
4. current enrollment in another investigational study; with the exception of study m12-963, which is required.
boolean
C2348568 (UMLS CUI [1])
C0008972 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
Study Subject Inappropriate ABT-122
Item
5. consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive abt-122.
boolean
C0681850 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C4547412 (UMLS CUI [1,3])