Inclusion criteria All Fulfill
Item
patients eligible for inclusion in this extension phase have to meet all of the following criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Therapeutic procedure Clinical Trial Specified
Item
1. patient is currently on treatment in the core study camn107ecn02
boolean
C0087111 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Patient Receiving Benefit | Therapeutic procedure Clinical Trial Specified
Item
2. patient who continues to derive benefit more than risk from the study treatment he/she takes in camn107ecn02, in the opinion of the investigator at the end of the study
boolean
C0030705 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0814225 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Informed Consent
Item
3. written informed consent must be obtained prior to enrolling in the extension study.
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria Any Fulfill
Item
patients eligible for this extension phase must not meet any of the following criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Progression Accelerated phase chronic myologenic leukemia | Progression Chronic myelogenous leukemia with crisis of blast cells
Item
1. progression to cml-ap or bc
boolean
C0449258 (UMLS CUI [1,1])
C0919870 (UMLS CUI [1,2])
C0449258 (UMLS CUI [2,1])
C2861579 (UMLS CUI [2,2])
Therapeutic procedure Clinical Trial Specified Inappropriate
Item
2. patient whose treatment assigned in camn107ecn02 is not appropriate any longer, per investigator's assessment.
boolean
C0087111 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C1548788 (UMLS CUI [1,4])
Treatment Compliance Lacking | Unreliable behavior | Uncooperative behavior
Item
3. history of non-compliance to medical regimens, or patients who are considered potentially unreliable and/or not cooperative.
boolean
C4319828 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C4061925 (UMLS CUI [2])
C0424350 (UMLS CUI [3])
Pregnancy | Childbearing Potential | Exception Childbearing Potential Contraceptive methods
Item
4. women who are (a) pregnant and (b) women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and at least 14 days after last dose of study medication. highly effective contraception methods include:
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C3831118 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Total abstinence | Periodic abstinence | Rhythm method of contraception | Oral contraception | Temperature method of contraception | Withdrawal - birth control
Item
total abstinence (when this is in line with the preferred and usual lifestyle of the subject. periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
boolean
C0234008 (UMLS CUI [1])
C1256761 (UMLS CUI [2])
C0035513 (UMLS CUI [3])
C0029151 (UMLS CUI [4])
C0419534 (UMLS CUI [5])
C3812880 (UMLS CUI [6])
Female Sterilization | Bilateral oophorectomy | Hysterectomy | Tubal Ligation
Item
female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. in case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
boolean
C0015787 (UMLS CUI [1])
C0278321 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0520483 (UMLS CUI [4])
Male sterilization | Partner had vasectomy
Item
male sterilization (at least 6 months prior to screening). for female subjects on the study the vasectomized male partner should be the sole partner for that subject.
boolean
C0024559 (UMLS CUI [1])
C0420842 (UMLS CUI [2])
Combination Criteria
Item
combination of any two of the following (a+b or a+c, or b+c):
boolean
C0205195 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
Oral contraception | Injectable contraception | Contraceptive implant | Hormonal Contraception | Vaginal ring contraceptive method | Transdermal patch as birth control method
Item
1. use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
boolean
C0029151 (UMLS CUI [1])
C1262153 (UMLS CUI [2])
C1657106 (UMLS CUI [3])
C2985296 (UMLS CUI [4])
C4761166 (UMLS CUI [5])
C2135981 (UMLS CUI [6])
Placement of intra-uterine device (IUD) | Placement Intrauterine System
Item
2. placement of an intrauterine device (iud) or intrauterine system (ius)
boolean
C3514961 (UMLS CUI [1])
C1533810 (UMLS CUI [2,1])
C4293370 (UMLS CUI [2,2])
Contraception, Barrier | Female Condoms | Diaphragm/cervical cap | Spermicidal foam/jelly/cream/film/suppository | Oral contraception
Item
3. barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository in case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
boolean
C0004764 (UMLS CUI [1])
C0221829 (UMLS CUI [2])
C3840973 (UMLS CUI [3])
C3843415 (UMLS CUI [4])
C0029151 (UMLS CUI [5])
Postmenopausal state | Childbearing Potential Absent | Amenorrhea | Bilateral oophorectomy | Hysterectomy | Tubal Ligation
Item
women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
boolean
C0232970 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0002453 (UMLS CUI [3])
C0278321 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0520483 (UMLS CUI [6])