--- a
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+Female participants who are pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta (b)-human chorionic gonadotropin (b-hCG) or urine pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Pregnant women are excluded from this study; breastfeeding should be avoided; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin [?-hCG]) at the Screening Visit and the Baseline Visit. A pregnancy test needs to be performed within 72 hours of the first dose of study drug. Females of childbearing potential must agree to use a highly effective method of contraception for the entire study period and for 120 days after study discontinuation, ie
+Women of childbearing potential must have a negative beta-human chorionic gonadotropin (B-HCG) pregnancy test documented within 14 days prior to registration
+Subjects who have a positive serum human chorionic gonadotropin (hCG), are pregnant or lactating are ineligible
+Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin [beta-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG [or hCG]); a separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Women of childbearing potential (WOCBP) only: Negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG])\r\n* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
+Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab
+Pregnant or nursing (lactating) women, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 10 mIU/mL); pregnancy is ruled out by a beta hCG test completed if necessary with an ultrasound
+Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ribociclib; pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)
+Women of childbearing potential (WOCPB) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours of starting study therapy
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation, confirmed by a positive hCG laboratory test
+Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin pregnancy test within 7 days prior to Day 1.
+Negative pregnancy test (urine or serum beta human chorionic gonadotropin [b-hCG]) at Screening for women of child bearing potential who are sexually active
+Negative urine ?-human chorionic gonadotropin (?-HCG) pregnancy test for fertile women at screening and confirmed by serum pregnancy test in the 48 hours prior to OPN-305 administration
+Serum creatinine ?1.5 mg/dL or a measured creatinine clearance ?60 mL/min; and Negative serum ? hCG (human chorionic gonadotropin) test in women of childbearing potential (defined as women ?50 years of age, or >50 years of age with a history of amenorrhea for ?12 months prior to study entry).
+Women of childbearing potential who currently are pregnant (human chorionic gonadotropin positive [HCG+]) or who are not practicing adequate contraception
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
+Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 7 days prior to the first dose of brentuximab vedotin and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug; females of non-childbearing potential are those who are post-menopausal for more than 1 year or who have had a bilateral tubal ligation or hysterectomy
+WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 0 to 48 hours before the first dose of study drug
+Females of child-bearing potential must have a negative serum beta human chorionic gonadotropin (HCG) test and be willing to use effective contraception (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) up to day 180
+Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of child-bearing potential
+Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial; pregnant women are excluded from this study; breastfeeding is not allowed during the course of the study; female patients must have a negative pregnancy test (human chorionic gonadotropin beta subunit [B-HCG] test in urine or serum) prior to commencing study treatment
+Females who are pregnant (beta-human chorionic gonadotropin positive [beta-HCG+]) or breast-feeding
+Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab
+Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropic [HCG]) within 24 hours prior to the start of the study drug
+PHASE II INCLUSION CRITERIA: Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropic [HCG]) within 24 hours prior to the start of the study drug
+Patient must be non-pregnant and non-nursing; women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to randomization
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
+Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 International units per liter [IU/L] or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
+Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours of the start of study drugs
+Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [?-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 International Units per Liter [IU/L] or equivalent units of ?-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
+Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab; elevated HCG for other explained and documented reasons is allowed
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Female patients of child-bearing potential (pre-menopausal and not surgically sterilized) who are breast-feeding or have a positive blood beta-human chorionic gonadotropin pregnancy test at Screening
+Ability to become pregnant (or already pregnant or lactating); women and men who want to participate have to agree to use two highly effective forms of contraceptive prior to study entry, for the duration of study participation, and for 30 days following completion of therapy, to be eligible; women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug
+Women of childbearing potential (WOCBP) must have a negative serum test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the start of investigational product
+Female subjects who are nursing or pregnant (positive serum or urine beta-human chorionic gonadotropin [B-hCG] pregnancy test)
+Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab
+Have a negative beta-human chorionic gonadotropin (?-hCG) pregnancy test at time of study entry and within 14 days prior to planned first dose of investigational product, and
+Are pregnant or nursing (lactating), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotropin (hCG) laboratory test
+Women of childbearing potential must have a negative serum pregnancy test (minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) performed within 24 hours prior to the start of nivolumab; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
+Pregnant or breast-feeding patients; women of childbearing potential must have a pregnancy test (minimum sensitivity of 25 IU/L or equivalent units of HCG) performed within 24 hours prior to the start of nivolumab, and a negative result must be documented before start of treatment
+Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Adolescent women/young women of childbearing potential must have a negative highly sensitive serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at Screening before enrollment/randomization. Adolescent/young women who are pregnant or breastfeeding are ineligible for this study
+Pregnancy (assessed by urine HCG)
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)
+Female of childbearing potential must have a negative serum beta-human chorionic gonadotropin (HCG) pregnancy test result within 3 days of first study dose; female patients who are surgically sterilized or who are > 45 years old and have not experienced menses for > 2 years may have beta-HCG pregnancy test waived
+Patients who are women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented =< 7 days prior to registration
+Pregnancy or the possibility of becoming pregnant during vaccine administration. Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-human chorionic gonadotropin [HCG]) prior to administration of the first vaccine dose. Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination. Women must also not be breast feeding. This is consistent with existing standards of practice for vaccine and chemotherapy protocols.
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 30 mIU/mL); laboratory values > 5 mIU/mL, but < 30 mIU/mL should be repeated in 48 hours
+Women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening
+DONOR: females who are pregnant (positive serum beta-human chorionic gonadotropin [B-HCG]) or uninterruptible breastfeeding
+Female subjects who are nursing or pregnant (positive serum or urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test) at screening or pre-dose on day 1
+PART I: Negative serum beta human chorionic gonadotropin (HCG) if female and of childbearing potential
+PART II: Negative serum beta HCG if of childbearing potential
+Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
+Pregnancy (absence to be confirmed by beta-human chorionic gonadotropin test in women of child-bearing potential) or lactation
+Negative serum beta-human chorionic gonadotropin (HCG) in females, and agreement to the use of effective contraception in males and females of childbearing potential, IS REQUIRED
+Performed within 10 business days of treatment initiation with the exception of beta-human chorionic gonadotropin (HCG) (72 hours), if applicable: Absolute neutrophil count (ANC) >= 1000 /uL.
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG] hormone) within 24 hours prior to the start of study drug
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Pregnant or breastfeeding women who do not consent to stop breast-feeding while on study treatment and for 30 days after the use of the investigational vaccine where pregnancy is confirmed by a positive, rising human chorionic gonadotropin (hCG) laboratory test
+Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to registration
+Positive urine pregnancy test (women of child bearing potential only) (QuickVue One Step human chorionic gonadotropin [hCG])
+Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin or urine pregnancy test at screening
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 1 days prior to the start of study drug
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
+Participants who are women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 72 hours prior to the start of study drug
+Positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization;
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening, within 24 hours of the first dose of anti-OX40 antibody, and every four weeks while on study treatment; women who are pregnant or breastfeeding are ineligible for this study
+Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine
+Female patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [hCG]) within 2 weeks of protocol entry if the patient is unsure of their pregnancy status. Patient signature declaring that they are not pregnant on the informed consent for treatment that is used in the Department of Radiation Oncology is also an acceptable substitution for a serum pregnancy test.
+A woman of childbearing potential who is sexually active must have a negative pregnancy test (beta human chorionic gonadotropin [beta hCG]) at Screening (urine or serum)
+Females of childbearing potential must have a negative beta human chorionic gonadotropin (?-hCG) pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
+Female patients who are pregnant (positive beta-HCG) or breastfeeding.
+Pregnant or nursing female participants, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 21 days of the study enrollment
+Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 21 days of study enrollment
+WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of investigational product.
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of the study drug.
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) during screening and within 48 hours prior to the first dose of nivolumab
+WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of investigational product.
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug
+Pregnant or breastfeeding - methotrexate is Pregnancy Category X - has been reported to cause fetal death and/or congenital abnormalities. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
+Negative serum beta-human chorionic gonadotropin (hCG) pregnancy test within 72 hours of day 1 of induction chemotherapy in women of child-bearing potential
+Negative beta-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause
+Female patients who are pregnant confirmed by beta human chorionic gonadotropin (bHCG) laboratory (lab) test
+Pregnant or lactating female: Women of childbearing potential (WOCB) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the start of nivolumab; Women of childbearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes
+Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [?-hCG] test with a minimum sensitivity of 25 International Units per Liter [IU/L] or equivalent units of ß-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. Females of childbearing potential (all females will be considered to be of childbearing potential unless they are postmenopausal [amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause] or have been sterilized surgically [ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing]) who:
+WOCBP must have a negative serum test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the start of investigational product
+Female subjects who are nursing or pregnant (positive serum or urine Beta-human chorionic gonadotropin [B-hCG] pregnancy test)
+Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-human chorionic gonadotropin [hCG]) pregnancy test result within 7 days prior to the first dose of study drugs and must agree to use both a highly effective method of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days after the last dose of study drug. Women of non- childbearing potential are those who are postmenopausal (defined as absence of menses for >= 1 year) or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use effective contraception, defined above, during the study and for 30 days following the last dose of study drug
+Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin positive [beta-HCG+]) or breast feeding
+Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab
+Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG])
+Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on study.
+Negative beta-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause; [women are considered postmenopausal if they are >= 12 months without menses, in the absence of endocrine or anti-endocrine therapies]
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug
+Women of child-bearing potential MUST have a negative serum or urine human chorionic gonadotropin (HCG) test unless prior hysterectomy or menopause (defined as 12 consecutive months of amenorrhea). Subjects should not become pregnant or breastfeed while on this study. Sexually active subjects must agree to use contraception for the duration of study participation and for 4 months after the last dose of neratinib and everolimus, palbociclib or trametinib.
+Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.
+Pregnant or breastfeeding; for elotuzumab arm: women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 14 days of study treatment start (24 hours prior to the start of elotuzumab)
+Normal beta-human chorionic gonadotropin (HCG) (per the local laboratory assay) within 14 days of RPLND
+Female patients of childbearing potential must have a negative serum beta?human chorionic gonadotrophin (?-hCG) pregnancy test at screening and negative urine pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
+Subject is pregnant or nursing; serum or urine beta-human chorionic gonadotropin (HCG) must be checked in all non-postmenopausal patients or patients of childbearing potential
+Negative beta human chorionic gonadotropin (HCG) in woman with child-bearing potential
+Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 14 days before study entry; pregnancy test must be repeated if performed > 14 days before starting study drug
+Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening and within 14 days prior to planned first dose of ribociclib
+Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Women must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product
+Female subjects of childbearing potential should have a negative urine or serum pregnancy test beta human chorionic gonadotropin (beta-hCG) within 72 hours prior to receiving the first dose of study medication
+Positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
+Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to registration; women of childbearing potential must not be pregnant, must not be breast-feeding, and must practice adequate contraception for the duration of the study, and for 30 days after the last dose of study medication
+Negative beta-human chorionic gonadotropin (hCG) pregnancy test for female patients of child-bearing potential =< 7 days before starting neratinib therapy
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
+A willingness to avoid pregnancy or fathering children in male and female subjects respectively:\r\n* A woman of childbearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and must be willing to avoid pregnancy during the treatment period and for a specified duration (1 year post hematopoietic cell transplant [HCT]) after the end of treatment\r\n* Women of childbearing potential who have a negative serum pregnancy test at screening must practice a highly effective method of birth control (with at least 99% certainty) from screening through safety follow-up; permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the subject and their understanding confirmed\r\n* Men who are enrolled must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through safety follow-up; permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the subject and their understanding confirmed
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug
+WOCBP who have a positive beta-human chorionic gonadotropin (hCG) test or are breastfeeding
+Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab; for WOCBP, follow up pregnancy tests will be performed every 4 weeks (+/-1 week) during the study regardless of dosing schedules
+Female patients who are diagnosed as pregnant by beta human chorionic gonadotropin (hCG) testing (per institutional practice) or breast-feeding
+Negative urine or serum beta-human chorionic gonadotropin (BHCG) for women of childbearing potential only (within 7 days of registration)
+For patients of childbearing potential, non-pregnant state, confirmed by negative serum or urine beta-human chorionic gonadotropin (HCG) within (7) days of planned radiation treatment
+Female patients who are pregnant (positive beta-human chorionic gonadotropin [B-HCG]) or breastfeeding
+Pregnancy or breast-feeding; women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test result within 14 days before the first dose of WT1-specific T cell infusion; woman of non-childbearing potential will be defined as being postmenopausal greater than one year or who have had a bilateral tubal ligation or hysterectomy; all recipients of WT1-specific T cells will be counseled to use effective birth control during participation in this study and for 12 months after the last T cell infusion
+Pregnant or nursing (to be confirmed with quantitative human chorionic gonadotropin [HCG] testing)
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive b-hCG laboratory test
+Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Negative beta-human chorionic gonadotropin (hCG) pregnancy test within 2 weeks before enrollment for premenopausal women of reproductive capacity and for women less than 12 months after menopause; pregnancy screening will be conducted for women up to the age of 50 years per institutional standard
+Negative urine beta-human chorionic gonadotropin (B-HCG) in women of child-bearing potential within 7 days prior to start of treatment
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the end of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to receiving nivolumab; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening and must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Negative beta human chorionic gonadotropin (HCG) in woman with child-bearing potential
+CAPMATINIB EXCLUSION CRITERIA: Pregnant or nursing women, or women intending to become pregnant during the study (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotropin [hCG] laboratory test); pregnant women are excluded from this study; nursing women are excluded unless they discontinue breastfeeding during the study
+Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (b-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception method during the study and for 23 weeks after the last dose of the study drug; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
+Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drugs; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
+Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females
+Pregnant or need to breast feed during the study period (negative beta-human chorionic gonadotropin [HCG] test required), or unable to maintain use of contraception while on study and for 31 weeks after the last dose of nivolumab
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Pregnancy (positive beta human chorionic gonadotropin [HCG] test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Females must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
+Pregnancy (assessed by urine HCG)
+Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab
+Negative serum or urine beta-human chorionic gonadotropin (beta-HCG) test (female of childbearing potential only), to be performed locally within the screening period
+Negative serum or urine beta-human chorionic gonadotropin (B-HCG) test (female patient of childbearing potential* only), to be performed locally within the screening period
+Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the first administration of study treatment; urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment
+Negative beta-human chorionic gonadotropin (HCG) test in a woman of child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
+WOCBP must have a negative serum test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the start of investigational product
+Female patients of childbearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin [hCG]) within 2 weeks of protocol entry
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
+DONOR: Female donors of child-bearing potential must have a negative serum or urine beta-human chorionic gonadotropin (HCG) test within three weeks of mobilization
+Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. Cohort 3B (Combination Expansion): Osteosarcoma participants who progressed in Cohorts 1 or 2B and opt to receive combination therapy.
+Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test (unless there is reasonable certainty that beta-hCG is coming from the tumor); pregnancy testing is not required for post-menopausal or surgically sterilized women
+Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for female patients of childbearing potential
+All post-menarchal females must have a negative serum beta-human chorionic gonadotropin (beta HCG); sexually active patients of childbearing potential must agree to use an effective method of contraception during the study and for at least 6 months after
+Documented negative serum beta-human chorionic gonadotropin (HCG) for female patients who are post-menarchal; pregnant females will not be included in the study; males and females must agree to use effective birth control methods during the course of vaccination (from the first vaccine to two weeks after the last vaccine); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; breastfeeding should be discontinued if the mother is treated in this study
+Patients may not be pregnant or breast feeding; females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 14 days prior to the first dose of S-equol
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 3 days prior to the start of study drug
+Negative serum or urine pregnancy test beta-human chorionic gonadotropin (beta hCG) within 2 weeks prior to receiving the first dose of study medication for women of childbearing age
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
+Negative pregnancy test (beta [B]-human chorionic gonadotropin [HCG]) within 7 days prior to registration for women of childbearing potential
+Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of child-bearing potential within one week prior to enrollment
+Negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening for patients of childbearing potential
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
+Women of childbearing potential must have a negative beta (B)-human chorionic gonadotropin (HCG) pregnancy test documented within 7 days prior to registration
+Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Female patients with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)
+DONOR:\r\n* Donors will be excluded if they are an identical twin of the recipient\r\n* Females who are pregnant (positive serum beta human chorionic gonadotropin beta [? HCG]) or uninterruptible breastfeeding\r\n* HIV seropositive\r\n* Donors receiving experimental therapy or investigational agents unless approved by the protocol chair
+Negative serum beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) (to be performed within 7 days prior to start of study treatment)
+Female patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [BhCG]) within 2 weeks of protocol entry
+Pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive beta-human chorionic gonadotropin (HCG) laboratory test
+Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months and no previous surgical sterilization
+Females of childbearing potential (> 7 years old [yo]) must have a negative serum or urine beta-human chorionic gonadotropin (HCG) test prior to initiation of cytoreductive therapy; sexually active patients will be informed of the risk of not using adequate contraception
+Negative serum beta-human chorionic gonadotropin (HCG)
+Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to treatment
+Women must not be pregnant or lactating; women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) serum pregnancy test and agree to refrain from breast-feeding; patients of childbearing potential agree to use an effective form of contraception during chemotherapy and for 90 days following the last chemotherapy treatment
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)
+Negative serum or urine beta-human chorionic gonadotropin (b-hCG) pregnancy test at screening for patients of childbearing potential
+Women of childbearing potential who currently are pregnant (beta-human chorionic gonadotropin [HCG]+) or who are not practicing adequate contraception
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
+Pregnant or lactating females; women of non-childbearing potential is defined as women who are postmenopausal (no menses for > one year) or who have had a hysterectomy and will not require beta-human chorionic gonadotropin (B-hCG) testing
+DONOR: Not be pregnant as defined by negative serum (beta human chorionic gonadotropin [beta HCG]) pregnancy test in females of childbearing potential (non-childbearing potential defined as premenarchal, previous surgical sterilization, or postmenopausal for > 12 months)
+Women of childbearing age must have a negative serum pregnancy test (beta-human chorionic gonadotropin) within 72 hours prior to initiating the conditioning regimen and be willing to not become pregnant by using effective contraception while undergoing treatment and for at least 3 months after the last dose of azacitidine
+Pregnancy (positive beta human chorionic gonadotropin [HCG] test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Pregnancy or breast-feeding; women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test result within 14 days before the first dose of WT1-specific T cell infusion; woman of non-childbearing potential will be defined as being postmenopausal greater than one year or who have had a bilateral tubal ligation or hysterectomy; all recipients of WT1-specific T cells will be counseled to use effective birth control during participation in this study and for 12 months after the last T cell infusion
+DLI DONOR: Females of childbearing potential should have a negative serum beta-human chorionic gonadotropin (HCG) test within 1 week of beginning apheresis
+Women of childbearing potential must have a negative serum or urine pregnancy test (sensitivity < 25 IU human chorionic gonadotropin (HCG)/L) within 72 hours prior to the start of study drug
+Female patients of childbearing age will be excluded if they are pregnant as assessed by serum beta-human chorionic gonadotropin (b-HCG) or urine pregnancy test; a serum b-HCG test or urine pregnancy test will be performed no greater than 14 days prior to study registration
+Women who are pregnant (determined by high titer of serum beta-human chorionic gonadotropin [HCG]) or breast-feeding; (women with reproductive potential must practice adequate contraception)
+Female patient of childbearing potential must have a negative serum or urine pregnancy test beta-human chorionic gonadotropin (hCG) within 72 hours prior to receiving the first dose of study medication and agree to the use of effective methods of contraception while on study
+Pregnant or nursing women; women of child-bearing age must be tested for urinary or plasma beta-human chorionic gonadotropin (hCG)
+Female patients of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [B HCG]) within 72 hours of receiving the first dose of rituximab
+Women of childbearing potential must have a negative beta-human chorionic gonadotropin (B-HCG) pregnancy test documented within 7 days prior to taking the first dose of study medications
+Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (?-human chorionic gonadotropin) within 7 days prior to randomization.
+For female patients of childbearing potential (i.e. have had a menstrual period within the past 12 months): a positive serum pregnancy test (?-human chorionic gonadotropin) within 7 days prior to enrollment.
+Pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
+Documented negative serum beta human chorionic gonadotropin (HCG) for female patients who are post-menarchal; males and females must agree to use effective birth control methods during the course of vaccination (from the first vaccine to two weeks after the last vaccine); should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
+Women of childbearing potential who currently are pregnant (beta-Human chorionic gonadotropin positive [HCG+]) or who are not practicing adequate contraception
+Subject is pregnant, has a positive serum human chorionic gonadotropin (hCG) or is lactating
+Subjects who are pregnant, have a positive serum human chorionic gonadotropin (hCG) or are lactating
+and, have a negative serum pregnancy test at Screening, (Note: Subjects with elevated serum beta human chorionic gonadotropin (?hCG) and a demonstrated non-pregnant status through additional testing are eligible), and
+Pregnancy, breastfeeding, contraception: Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic [?-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 International Units per Liter [IU/L] or equivalent units of ?-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
+Female subjects of childbearing potential must have a negative serum human chorionic gonadotropic (hCG) test within 1 week of Day 1 (pregnancy test not required for subjects with bilateral oophorectomy and/or hysterectomy or for those subjects who are >1 year post-menopausal); and
+A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at Screening and a negative urine pregnancy test prior to the first dose of study drug
+Women who are breastfeeding or who are pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) performed within 14 days of the first dose of study drug and by a urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours of the first dose of study drug(s).
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test.
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcG laboratory test.
+Female patients of childbearing age are excluded if they are pregnant as determined with a serum beta HCG no greater than 14 days prior to study registration, or breast-feeding. (The exclusion is made because gadolinium may be teratogenic in pregnancy).
+Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 24 months or no previous surgical sterilization and willing to ongoing pregnancy testing while on treatment with lenalidomide
+WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours before the start of ipilimumab
+Negative serum pregnancy test (serum HCG) within 7 days of study treatment if female and of childbearing potential (non-childbearing is defined as greater than one year post-menopausal surgically sterilized). Since beta-HCG may be falsely elevated as a result of malignancy, women of child-bearing potential who have an elevated serum beta-HCG level are eligible for enrollment if they have two Transvaginal Ultrasound (TVUS) scans one week apart along with serial beta-HCG levels two weeks apart that are inconsistent with pregnancy and a Gynecology consult to ensure that the beta- HCG level was at a value high enough to see pregnancy with TVUS.
+Not pregnant based on a negative result on a serum human chorionic gonadotropin (HCG) test at screening Visit 1 and a negative urine pregnancy test prevaccination at Visit 2 (and at subsequent vaccination visits);
+Beta human chorionic gonadotropin (beta HCG) negative
+Negative serum beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) performed locally within 72 hours (hrs) prior to first dose
+All post-menarchal females must have a negative beta-HCG
+Negative beta human chorionic gonadotropin (HCG) in woman with child-bearing potential
+Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females.
+FOCBP must have a negative pregnancy test (beta-human chorionic gonadotropin [HCG] test in urine or serum) within 7 days prior to registration on study (Note: The test will have to be repeated if cycle 1 day1 is more than 3 days from registration)
+Female patients who are pregnant (positive beta-human chorionic gonadotropin [b-HCG]) or breast feeding.
+Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening
+Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (B-hCG) pregnancy test result within 14 days prior to the first dose of imipramine
+Pregnant women are excluded from this study, where pregnancy is confirmed by a positive serum beta-human chorionic gonadotropin (hCG) laboratory test; breast-feeding should be discontinued
+Pregnant or or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
+Negative serum or urine beta-human chorionic gonadotropin (HcG) test (female patient of childbearing potential only) performed within 72 hours of prior to first study dose
+The subject must have a negative serum beta-human chorionic gonadotropin (beta-HCG) pregnancy test at screening, if a female of child bearing potential. Additional urine pregnancy tests may be done per institutional requirements. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for 90 days afterward if treated with maribavir, ganciclovir, valganciclovir, or cidofovir and for 180 days afterward if treated with foscarnet.
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of thoracic radiation therapy
+A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin [b-hCG]) or urine test prior to the first dose of study drug
+Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 21 days of study enrollment
+DONOR: Female donors of child-bearing potential must have a negative serum or urine beta-human chorionic gonadotropin (HCG) test within two weeks of apheresis
+Pregnant women or women who are breastfeeding are excluded from this study; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Women of childbearing potential (WOCBP) must have a negative pregnancy test (minimum sensitivity 25 IU/L or equivalent of human chorionic gonadotropin [HCG]) before entry onto the trial
+Women of childbearing potential must have a negative serum ?-human chorionic gonadotropin or urine pregnancy test at screening
+Women of childbearing potential (WOCBP) must have a negative pregnancy test (minimum sensitivity 25 IU/L or equivalent of human chorionic gonadotropin [HCG]) before entry onto the trial and within 7 days prior to start of study medication; it is the investigators’ responsibility to repeat the pregnancy test should start of treatment be delayed
+DONOR: Female donors of child-bearing potential must have a negative serum or urine beta-human chorionic gonadotrophin (HCG) test within three weeks of mobilization
+Pregnancy during vaccine administration; female participants of childbearing potential must have a negative pregnancy test (serum beta human chorionic gonadotropin [B-HCG]) prior to administration of the first vaccine dose
+Women who are pregnant or breast-feeding; women of reproductive potential must have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test obtained within 7 days before the start of study treatment
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL); patients with elevated hCG at baseline that is judged to be related to the tumor are eligible if hCG levels do not show the expected doubling when repeated 5-7 days later, or pregnancy has been ruled out by vaginal ultrasound
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)
+Women who are pregnant or breastfeeding; women of child-bearing potential must have a negative pregnancy test (beta- human chorionic gonadotropin [B-HCG] test in urine or serum) prior to commencing study treatment
+Negative serum beta-human chorionic gonadotropin (beta-hCG) test (women of childbearing potential only)
+Women of childbearing potential must have a negative serum beta (B)-human chorionic gonadotropin (HCG) pregnancy test at initial screening and within 3 days prior to registration
+Pregnancy: All subjects will have a beta-human chorionic gonadotropin (hCG) serum pregnancy test to rule out pregnancy, a history will also be taken to make certain that recent sexual exposure does not put them at risk for pregnancy; if so a second serum pregnancy test will be done; volunteers will be asked to use barrier contraception during study
+Female patients of childbearing potential has a negative serum pregnancy test beta-human chorionic gonadotropin (hCG)
+Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women
+Women of childbearing potential who currently are pregnant (beta-human chorionic gonadotropin [HCG]+) or who are not practicing adequate contraception or who are breastfeeding
+Woman of childbearing potential must have 2 negative highly sensitive serum (beta-human chorionic gonadotropin [b-hCG]) during screening, the first one within 10 to 14 days prior to the first dose of any component of study treatment and the second within 24 hours prior to the first dose of any component of study treatment
+Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
+Females of childbearing potential must have a negative beta human chorionic gonadotropin (?-hCG) pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)
+Women of childbearing potential must have a negative urine or serum beta-human chorionic gonadotropin pregnancy test within 7 days prior to Day 1.
+Female participants of childbearing potential must have 2 negative urine human chorionic gonadotropin tests within 10 to 14 days and within 24 hours prior to receiving study medication
+Negative ?-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause. [Women are considered postmenopausal if they are ?12 months without menses, in the absence of endocrine or anti-endocrine therapies.]
+Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 international units/liter (IU/L) or equivalent units of ß-hCG [or hCG]). A separate Baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
+Female subject pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for women without child-bearing potential
+Negative blood or urine beta-human chorionic gonadotropin (?- HCG) pregnancy test within 7 days prior to Day 1 for women of childbearing potential.
+Female participants of reproductive potential must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)
+Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Females of childbearing potential must: use appropriate method(s) of contraception; women of childbearing potential (WOCBP) should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug; women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study; females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategies (REMS) program
+Females must not be lactating or pregnant at screening or baseline (as documented by a negative beta-human chorionic gonadotropin [B-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
+A woman of childbearing potential must have a negative highly sensitive serum [beta-human chorionic gonadotropin (?-hCG)] or urine pregnancy test at (minimum sensitivity 25 International units (IU)/ liter (L) or equivalent units of HCG) within 7 days prior to the first dose of study drug
+Pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive beta-human chorionic gonadotropin (HCG) laboratory test
+Females of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test result within 7 days prior to the first dose of ibrutinib; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
+Pregnant and/or lactating females are excluded; a negative beta-human chorionic gonadotropin [B-hCG]) is required during Screening, and a separate local assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of Test Article
+Negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening for patients of childbearing potential
+Pregnant women or women who are breastfeeding are excluded from this study; confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)
+Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females
+Negative serum or urine beta-human chorionic gonadotropin (HCG) pregnancy test at screening for patients with childbearing potential
+Women must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to the start of investigational product
+Women of childbearing potential with a positive serum beta human chorionic gonadotropin (hCG)
+Females of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test result within 7 days prior to the first dose of SGN-35; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
+Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [B-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
+Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women
+Female patients who are pregnant (positive b-human chorionic gonadotropin [HCG]) or breastfeeding
+Women who are breastfeeding or who are pregnant as evidenced by a positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) performed within 14 days of the first dose of study drug and by a urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours of the first dose of study drug(s)
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 7 days prior to the start of nivolumab.
+Negative serum pregnancy test (beta human chorionic gonadotropin [beta HCG]) within 7 days of starting study, if of child-bearing potential
+Female patients who are pregnant (positive beta-human chorionic gonadotropin [HCG]) or breastfeeding will be excluded from study entry; sexually active men and women must use contraceptive techniques during and for 4 weeks following completion of maintenance therapy
+A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta- hCG]) at Screening within 14 days prior to study drug administration Inclusion Criteria for Crossover:
+WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study treatments
+Pregnancy or breast feeding; female patients must have a negative pregnancy test (beta-human chorionic gonadotropin [HCG] test in urine or serum) prior to commencing study treatment and must agree with the use of effective contraception during the study and for three months following last dose of nintedanib
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
+Female participants must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
+Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [Beta-hCG]) pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study; females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program
+Pregnant or breastfeeding - interferon products (e.g., Infergen®) is Pregnancy Category C, (i.e., animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans.). Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (?-HCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
+WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of investigational product
+Positive beta human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females
+Negative pregnancy test (serum beta-human chorionic gonadotropin [B-HCG]) within 7 days of starting study treatment is required in women of childbearing potential; NET patients with positive B-HCG are eligible if pregnancy can be excluded by vaginal ultrasound or lack of expected doubling of B-HCG
+Pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (greater than 5 mIU/mL)
+Women of childbearing potential (less than 12 consecutive months since last regular menses, or surgically sterile) must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test and must agree to use hormonal, intrauterine device (IUD), or barrier birth control with spermicide to avoid pregnancy during the study; agreement to participate in this study via the informed consent will indicate subjects commitment to subject avoid pregnancy in self or a partner of childbearing potential for up to 6 months after the last dose of study therapy
+Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive serum human chorionic gonadotropin (hCG) laboratory test of > 5 mIU/mL
+Women of child-bearing potential MUST have a negative serum or urine human chorionic gonadotropin (HCG) test unless prior tubal ligation (>= 1 year before screening), total hysterectomy or menopause (defined as 12 consecutive months of amenorrhea); patients should not become pregnant or breastfeed while on this study; sexually active patients must agree to use dual contraception for the duration of study participation and for 120 days after the last dose of talazoparib
+Negative serum pregnancy test (beta-human chorionic gonadotropin [B-hCG]) within 72 hours before starting study treatment for all women of childbearing potential
+Pregnant nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
+Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 7 days prior to treatment
+The patient is pregnant (confirmed by serum beta human chorionic gonadotropin [b-HCG], if applicable) or is breastfeeding
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 3 days before the start of ipilimumab
+Pregnant women or women who are breastfeeding are excluded from this study; confirmation that the subject is not pregnant must be established by a negative serum beta?human chorionic gonadotropin (beta?hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post?menopausal or surgically sterilized women
+DONOR: Females of childbearing potential should have a negative serum beta-human chorionic gonadotropin (HCG) test within 1 week of beginning growth factor of choice
+Pregnant or nursing (lactating) women are not eligible for participation; Note: Pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL)
+Negative urine beta-human chorionic gonadotropin (HCG) or negative serum quantitative beta-HCG or within 2 weeks prior to registration for women of childbearing potential
+Negative serum human chorionic gonadotrophin (HCG) pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after menopause
+Negative beta-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause
+Women of childbearing potential (including premenopausal women and women less than 12 months after menopause) must have a negative beta-human chorionic gonadotropin (hCG) urine pregnancy test within 4 weeks of registration
+Premenopausal women of child bearing potential must have a normal urine or serum beta-human chorionic gonadotropin (HCG) prior to enrollment, and must agree to use effective contraception during treatment with nivolumab and for at least 5 months following the last dose of nivolumab
+Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Females must not be breast-feeding or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [B-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is required if a negative Screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
+Women of childbearing potential must have a negative pregnancy test (serum or urine beta human chorionic gonadotropin [HCG]) prior to initiation of chemotherapy; both female and male breast cancer patients who are sexually active have to agree to practice contraception while participating in the trial and for 3 month after completion of therapy
+Patients will be excluded if they are pregnant as assessed by serum beta human chorionic gonadotropin (b-HCG); a serum b-HCG test will be performed no greater than 14 days prior to study registration for women of childbearing potential
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Pregnant (i.e., positive beta-human chorionic gonadotropin test) or lactating
+Women of child-bearing potential (WOCBP) must have a negative pregnancy test prior to enrollment and within 14 days of the first administration of study treatment, and must also agree to use effective contraception throughout the treatment period and for 4 months after the last dose of study treatment; urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment
+Is pregnant (confirmed by beta human chorionic gonadotrophin [?-HCG]) or lactating.
+Patient is pregnant (confirmed by serum beta- b-human chorionic gonadotropin [HCG] if applicable) or is breastfeeding
+Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
+HAPLO-IDENTICAL DONOR: Pregnancy (positive serum or urine beta-human chorionic gonadotropin [HCG]) or breastfeeding; women of childbearing age must avoid becoming pregnant while on the study
+Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women
+Positive pregnancy screening test with a minimum sensitivity of 25 IU/L of human chorionic gonadotropin (hCG) within 72 hours of registration; breastfeeding women are also excluded
+Females of child-bearing potential (pre-menopausal) must have a negative serum beta-human chorionic gonadotropin (HCG) pregnancy test at screening
+Negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test within 72 hours of day 1 of induction chemotherapy in women of child-bearing potential
+DONOR: Pregnancy (positive serum or urine beta-human chorionic gonadotropin [b-HCG]) or breastfeeding; women of childbearing age must avoid becoming pregnant while on the study
+Negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test within 72 hours of day 1 of treatment with ABVD in women of child-bearing potential
+Pregnant women with a positive (blood beta-human chorionic gonadotropin [B-HCG]) pregnancy test are excluded from this study
+Urine or serum beta-human chorionic gonadotropin (HCG) or serum HCG = negative (if female patient of childbearing potential)
+Negative beta human chorionic gonadotropin (HCG) test within 30 days in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization); pregnancy testing is not required for post-menopausal or surgically sterilized women
+WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotrophin [HCG]) within 72 hours before the start of ipilimumab
+Female patients with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening
+Women of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (B-HCG) pregnancy test documented within 72 hours of start of therapy
+Females of childbearing potential (a female not post-menopausal for at least 12 months or not surgically sterilized) must have a negative beta-human chorionic gonadotropin (HCG) pregnancy =< 7 days prior to day 1 of cycle 1; if the pregnancy test is outside institutional normal range at pretreatment, the subject must have a second pregnancy test; if the second pregnancy test is outside institutional normal range then a gynecology consult is needed to confirm the subject is not pregnant; all patients must agree to use an effective contraceptive method during the course of the study
+Female patient of childbearing potential must have a negative serum or urine pregnancy test (beta-human chorionic gonadotropin [hCG]) within 72 hours prior to receiving the first dose of study medication and agree to the use of effective methods of contraception while on study
+Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin positive [HCG+]) or breast feeding
+Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women (woman not of child-bearing potential is defined as any woman whose menstrual periods have stopped in the past 12 consecutive months or have had a complete hysterectomy or both ovaries surgically removed)
+Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+All females must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta-human chorionic gonadotropin [?-hCG]) at the screening visit and the baseline visit; a pregnancy test needs to be performed within 72 hours of the first dose of study drug
+Pregnancy (positive serum ?-HCG) or breastfeeding.
+Female patient of childbearing potential has a negative serum pregnancy test beta-human chorionic gonadotropin (b-hCG) within 7 days prior to receiving the first dose of vorinostat
+Female patients of childbearing potential (WOCBP) must have a negative serum pregnancy test beta-human chorionic gonadotropin (hCG) within 7 days of the first treatment
+Female subject pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotrophin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for women without child-bearing potential
+Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of child-bearing potential (this is routinely done if the patient is premenopausal and having surgery)
+Negative serum beta human chorionic gonadotropin (?hCG) test (for women of childbearing potential only)
+Patients of childbearing potential must agree to use some form of adequate birth control during the periods they receive chemotherapy and any post-chemotherapy medications related to the transplant; females of child bearing potential must have a negative serum beta-human chorionic gonadotropin (B-HCG) within 1 week of starting therapy
+DONOR: Females of childbearing potential should have a negative serum beta-human chorionic gonadotropin (HCG) test within 1 week of beginning G-CSF mobilization
+Pregnant or lactating women; a beta-human chorionic gonadotropin (HCG) level will be obtained from women of childbearing potential; fertile men and women should use effective contraception
+Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin positive [b-HCG+]) or breast feeding
+Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on study
+Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test (Unless there is reasonable certainty that beta-hCG is coming from the tumor). Pregnancy testing is not required for post-menopausal or surgically sterilized women.
+Female subject is either post-menopausal at least 1 year before the screening visit or surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) at the same time, from the time of signing the informed consent through 30 days after the last dose of study treatment, or agree to completely abstain from heterosexual intercourse; female subject is not pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Females must not be pregnant (negative human chorionic gonadotropin test within 72 hours prior to receiving the first dose of study medication) or breastfeeding
+Female participants must not be pregnant (negative urine or serum human chorionic gonadotropin test at screening and again within 72 hours prior to receiving the first dose of study therapy)
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [B-hCG]) or urine pregnancy test at screening
+Females of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (HCG) pregnancy test at screening; pregnancy testing is not required for: (a) women who have been post-menopausal for at least 2 years without menses; or (b) women who are surgically sterile (e.g. by means of hysterectomy, tubal ligation, etc.)
+Pregnancy: women of childbearing potential who are beta(B)-human chorionic gonadotropin (HCG) positive (+)
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening within 7 days of enrollment
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (at screening or baseline).
+Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening (within 7 days prior to D1 of treatment); pregnancy testing is not required for post-menopausal or surgically sterilized women
+Females must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
+Negative serum beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only), to be performed locally within the screening period
+Women of reproductive potential must have a negative serum beta human chorionic gonadotropin (b-HCG) pregnancy test within 7 days before the first dose of study drug. Women of reproductive potential and men with female partners of childbearing potential must agree to consistently use highly effective contraception between signing the informed consent and 60 days after the last administration of study drug
+Pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive beta (B)-human chorionic gonadotropin (HCG) laboratory test
+Negative beta human chorionic gonadotropin (HCG) test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and if fertile, males and females must agree to use contraceptives
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Negative beta human chorionic gonadotropin (bHCG) within 14 days prior to study entry if patient is pre or perimenopausal
+Negative pregnancy test (beta human chorionic gonadotropin [HCG]) within 14 days of study drug initiation for pre- or perimenopausal subjects with an intact uterus
+Negative serum beta-human chorionic gonadotropin (B-HCG) test (female patient of childbearing potential only) performed locally within 72 hrs prior to first dose
+Positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
+If a female patient is of childbearing potential, she must have a negative serum pregnancy test (beta-human chorionic gonadotropin [hCG]) documented within 72 hours of the first administration of study drug
+Male or non-pregnant and non-lactating female; if a female patient is of childbearing potential, she must have a negative serum pregnancy test (beta-human chorionic gonadotropin [b-hCG]) documented within 72 hours of the first administration of study drug
+Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) with 28 days prior to randomization
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test at screening for patients of childbearing potential
+Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [B-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 International units per litre (IU/L) or equivalent units of B-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
+Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of nivolumab
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin (hCG) laboratory test (> 5 mIU/mL). Patients with elevated hCG at baseline that is judged to be related to the tumor are eligible if hCG levels do not show the expected doubling when repeated 5 - 7 days later, or pregnancy has been ruled out by vaginal ultrasound.
+Female subjects must have a negative serum human chorionic gonadotropic (hCG) test (pregnancy test not required for subjects with bilateral oophorectomy and/or hysterectomy or for those subjects who are >1 year post-menopausal); and
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) during screening for eligibility assessments and enrollment and within 24 hours prior to the start of study drug.
+Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on study
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin hormone) within 24 hours prior to the start of study drug.
+Women should not be lactating and, if of childbearing age, should have a negative pregnancy test (beta-human chorionic gonadotropin [b-HCG] test; serum or urine, minimum sensitivity 25 IU/L or equivalent units of b-HCG) within two week of registration in the study
+A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening
+Pregnant women or women who are breastfeeding are excluded from this study; confirmation that the subject is not pregnant must be established by a negative serum beta (?)-human chorionic gonadotropin (?-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Have a negative pregnancy test Beta Human Chorionic Gonaditrophin(ß-hCG) as verified by the study doctor within 72 hours prior to starting study therapy.
+Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test within 14 days of day (D)1 of neoadjuvant chemotherapy for women of childbearing potential
+If female patient is of child bearing potential, she must have a negative serum pregnancy test (beta human chorionic gonadotropin [hCG]) documented up to 72 hours (hrs) prior to administration of first study drug
+Pregnant or breast feeding women; positive pregnancy test (serum or urine beta-human chorionic gonadotropin [HCG]) for women of reproductive potential
+Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 14 days prior to the first dose of brentuximab vedotin and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug; females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy
+Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women
+Negative serum beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) performed locally within 72 hours (hrs) prior to first dose
+Pregnant or nursing (lactating) women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
+Negative beta human chorionic gonadotropin (HCG) test in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
+Negative serum or urine beta-human chorionic gonadotropin (B-hCG) pregnancy test at screening, performed no more than 72 hours prior to treatment initiation; for women of childbearing potential
+Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to ongoing pregnancy testing while on treatment with lenalidomide
+Women of childbearing potential and all men must agree to use an approved form of contraception (e.g. oral, transdermal patch, implanted contraceptives, intrauterine device, diaphragm, condom, abstinence or surgical sterility) prior to study entry and for the duration of study participation through 30 days after the last dose of BL-8040. Confirmation that female subjects are not pregnant must be established by a negative serum ?-human chorionic gonadotropin (?-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
+Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum ?-human chorionic gonadotropin (?-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test
+Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening
+Women of childbearing potential who are lactating, pregnant or there is the likelihood of becoming pregnant within the coming 12 months; a positive serum beta-human chorionic gonadotropin test at time of screening for entry into study
+Pregnant females as determined by positive human chorionic gonadotropin (hCG) test at screening or prior to dosing.
+Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 14 days prior to registration
+Patients of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin) within 72 hours prior to receiving the first dose of study treatment.
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mlU/mL)
+Female patients of childbearing potential must have a negative serum pregnancy test (human chorionic gonadotropin beta subunit [B-hCG] pregnancy test) within 72 hours prior to receiving the first dose of vorinostat; male patients enrolled in this study should also agree to use an adequate method of contraception for the duration of the study
+WOCBP must have a negative serum or urine pregnancy test [minimum sensitivity 25 UI/L or equivalent units of human chorionic gonadotrophin (HCG)] within 24 hours prior to the start of investigational product
+Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Female subjects must not be pregnant as documented by a negative beta-human chorionic gonadotropin (beta-hCG) test with a minimum sensitivity 25 IU/L or equivalent unit of beta-hCG at Screening and Baseline, or breastfeeding.
+WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours before the start of ipilimumab
+DONOR: Females of childbearing potential should have a negative serum beta-human chorionic gonadotropin (HCG) test within 1 week of beginning apheresis
+Women should not be lactating and, if of childbearing age, should have a negative pregnancy test (beta-human chorionic gonadotropin [b-HCG] test; serum or urine, minimum sensitivity 25 IU/L or equivalent units of b-HCG) within two week of registration in the study
+Female subject is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening, unless the female has recently (within 8 weeks) undergone egg harvest, which would result in the (beta-hCG) test to be elevated without pregnancy; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Positive beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
+Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months and no previous surgical sterilization
+For female subjects of childbearing potential (i.e., have had a menstrual period within the past 12 months): a positive serum pregnancy test (?-human chorionic gonadotropin) within 7 days prior to enrollment; or unwilling or unable to undergo hormonal suppression to avoid menstruation during treatment
+Women must not be pregnant or breastfeeding; WOCBP must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 7 days prior to registration
+Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only)
+Negative beta human chorionic gonadotropin (HCG) in woman with child-bearing potential
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [b-hCG]) or urine pregnancy test within 7 days prior to treatment initiation and when clinically indicated every 4 weeks +/- 7 days while receiving study drugs, as shown in study calendar; women who are pregnant or breastfeeding are ineligible for this study
+Female subject who is pregnant or breast-feeding; confirmation that the subject is not pregnant must be established by a negative serum beta (b)-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening; pregnancy testing is not required for post-menopausal or surgically sterilized women
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
+Within 4 weeks of therapy start, women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening and must adhere to the scheduled pregnancy testing
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Negative beta human chorionic gonadotropin (HCG) test in woman with child bearing potential, defined as not post-menopausal for 12 months or no previous sterilization
+Negative serum beta (?) human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within 72 hours prior to first dose
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
+Positive beta-human chorionic gonadotropin (HCG) in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or lactating females
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
+Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL); patients with elevated hCG at baseline that is judged to be related to the tumor are eligible if hCG levels do not show the expected doubling when repeated 5-7 days later, or pregnancy has been ruled out by vaginal ultrasound
+WOCBP must have a negative serum or urine pregnancy test (sensitivity ? 25IU human chorionic gonadotropin [hCG]/L) within 72 hours prior to the start of study drug administration
+Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 21 days prior to registration
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study drug; women who undergo fertility preservation within 2 weeks of beginning chemotherapy are expected to have false-positive pregnancy tests and therefore testing may be waived for these patients\r\n* WOCBP must agree to follow instructions for method(s) of contraception from the time of enrollment for the duration of treatment with study drug plus 5 half-lives of study drug plus 30 days (duration of ovulatory cycle) for a total of 23 weeks post treatment completion\r\n* Women must not be breastfeeding
+Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [?-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 International Units [IU]/L or equivalent units of ?-hCG or hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
+Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening; women who are pregnant or breastfeeding are ineligible for this study
+A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum beta-human chorionic gonadotrophin [beta-hCG] test) in females of reproductive potential), not lactating or if of reproductive potential agrees to follow one of the options listed in protocol from 30 days prior to the first dose of study medication and until 120 days after the last dose of study treatment.
+Negative beta-human chorionic gonadotropin (betaHCG) pregnancy test among females of childbearing age
+Females who are pregnant, lactating, or intend to become pregnant during the participation of the study; childbearing age women who are not on birth control; positive pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and no history of menses within the last 12 months; pregnancy test to be performed on the day of enrollment; in cases of women with elevated beta-human chorionic gonadotropin (b-HCG), these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy and the non-pregnant status is confirmed by a gynecologic examination
+Pregnancy or breast feeding; female patients with child-bearing potential must have a negative pregnancy test (beta-human chorionic gonadotropin [B-HCG] test in urine or serum) prior to commencing study treatment
+If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study\r\n* Women < 50 years old must have a negative pregnancy test (urine human chorionic gonadotropin [HCG] or serum betaHCG) within 2 weeks of beginning chemotherapy
+Positive beta human chorionic gonadotropin (HCG) within 7 days prior to consent in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding
+Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration
+Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration
+Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration
+Being female and pregnant, breast-feeding or of childbearing potential; (note: lack of childbearing potential for female patients is satisfied by: a) being post menopausal; b) being surgically sterile; c) practicing contraception with an oral contraceptive, intra-uterine device, diaphragm, or condom with spermicide for the duration of the study; or d) being sexually inactive; confirmation that the patient is not pregnant will be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of enrollment
+Pregnancy (positive serum beta human chorionic gonadotropin [b-HCG]) or breastfeeding
+DONOR: Female donors of child-bearing potential must have a negative serum or urine beta-human chorionic gonadotropin (HCG) test within three weeks of apheresis
+Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
+Pregnant or breast-feeding; pre-menopausal patients must have a negative serum human chorionic gonadotropin (HCG) within 14 days of enrollment
+Women who are breast feeding or pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) done within 14 days of first dosing and urine test within 72 hours of first dosing
+Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive serum human chorionic gonadotropin (hCG) laboratory test of > 5 mIU/mL
+Women of childbearing age will be required to have a negative human chorionic gonadotropic (HCG) test within seven days of surgery
+Minocycline trial only: patients who are pregnant; pregnancy will be confirmed by negative urine test; patients with a positive urine test will be retested for doubling of human chorionic gonadotropin (HCG) 48 hours after the first test; patients without such a rise will be eligible for the study and will be enrolled at the investigator’s discretion
+Female subject is pregnant or lactating; confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test result obtained during screening; pregnancy testing is not required for postmenopausal or surgically sterilized women
+Positive pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated beta (b)-human chorionic gonadotropin (HCG), these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth control specifications: women who are able to become pregnant must use birth control during the study and for 30 days after
+Pregnant (i.e., positive beta-human chorionic gonadotropin [HCG]) or breast feeding
+Female subjects capable of reproduction must have a negative beta human chorionic gonadotropin (BHCG) serum or urine pregnancy test result within 7 days prior to first Investigational Product dose
+Negative pregnancy test (females of child bearing potential) within =< 1 week of rasburicase dose and use of efficient contraceptive method (both males and females); pregnancy test may be performed on serum (human chorionic gonadotropin [HCG]) or urine (HCG)
+Women who are pregnant or post-partum (within 3 months of delivery); patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta human chorionic gonadotropin (HCG), or best judgement of the investigator; pregnancy testing is not required per protocol to determine study eligibility; women who become pregnant on the ISDO arm via reproductive technology can remain on study; however, data collection will be suspended during pregnancy and 3 months post-partum
+Pregnancy (assessed by urine HCG)
+RECIPIENT: Negative serum or urine beta?human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration
+Pregnant or need to breast feed during the study period (negative urine beta-human chorionic gonadotropin [HCG] test required), or unable to maintain use of contraception while on study and for 1 month after the last dose of AED
+Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to surgery
+Females of childbearing potential are to agree to practice a medically acceptable contraceptive regimen (including a barrier method) from study treatment initiation until at least 30 days after the last administration of Folotyn or leucovorin, whichever is last, and are to have a negative urine beta human chorionic gonadotropin (?-HCG) pregnancy test within 14 days prior to the first day of study treatment. Females who are postmenopausal for at least 1 year (defined as >12 months since last menses) or are surgically sterilized do not require this test
+Women of child-bearing potential must also have a negative urine pregnancy test (beta-human chorionic gonadotropin [HCG]) within 72 hours of receiving treatment
+Women who are pregnant; patients are deemed not pregnant by virtue of urine pregnancy test (UPT), transvaginal ultrasound, beta human chorionic gonadotropin (HCG), or best judgement of the investigator, pregnancy testing is not required per protocol to determine study eligibility
+Pregnancy (urine hCG)
+Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
+Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
+Female patient who is pregnant or lactating (the possibility of pregnancy has to be excluded by negative serum or urine beta-human chorionic gonadotropin [?-HCG] results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)
+Pregnant or lactating patients will be excluded, as will females of childbearing potential who refuse to undergo a serum or urinary beta-human chorionic gonadotropin (HCG) pregnancy test the day of either the 18F-FSPG or the 18F-FDG PET/CT scans in accordance with the standard policy of the Medical Imaging Service at our facility; women who have experienced 24 consecutive months of amenorrhea, have reached at least 60 years of age, or have had a tubal ligation or hysterectomy documented in their medical records are considered not to be of childbearing potential for the purposes of this protocol
+Negative serum beta-human chorionic gonadotropin (beta-hCG) test (women of childbearing potential only)
+Any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating (the possibility of pregnancy has to be excluded by negative urine beta-human chorionic gonadotropin [beta-HCG] results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)
+Women of childbearing potential, unless they have had a negative urine beta human chorionic gonadotropin (betaHCG) within the previous 24 hours of the procedure
+All post-menarchal females must have a negative beta-human chorionic gonadotropin (HCG) within 2 weeks prior to receiving the dose of 124I-MIBG; males and females of childbearing potential must practice an effective method of birth control while participating on this study, to avoid possible damage to the fetus
+Women who are pregnant (confirmed by serum beta [b]-human chorionic gonadotropin [HCG] in women of reproductive age) or breast feeding
+Pregnant women and women who are breast feeding will be excluded from this study; (the Vanderbilt University Medical Center radiology “MRI Procedure Screening Form” will be used to identify and exclude subjects who are pregnant or breastfeeding; a urine pregnancy test/or serum beta human chorionic gonadotropin [HCG] will also be performed for each pre-menopausal subject)
+Women of childbearing potential, unless they have had a negative urine human chorionic gonadotropin (HCG) within the previous 24 hours of the procedure
+Negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours (hrs) prior to registration in women of child-bearing potential (WOCBP)
+Negative serum ? -HCG (beta human chorionic gonadotropin) test for female of child bearing potential at screening and a negative urine pregnancy test at Day 1.
+Negative serum beta-human chorionic gonadotropin (B-HCG) within 1 week of the study imaging with documentation of use of appropriate contraceptive measures (examples include abstinence, intrauterine device (IUD), hormonal methods (oral birth control pills, injections, implants), tubal ligation, and partner's successful vasectomy) after the B-HCG for females of childbearing potential
+Pregnant (confirmed by serum beta human chorionic gonadotropin [b-HCG] in women of reproductive age) or breast feeding
+Subjects who are pregnant or nursing; urine pregnancy test/or serum human chorionic gonadotropin (HCG) will be performed on women of child bearing potential
+Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [ß-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG).
+Women of childbearing potential must have a negative beta-human chorionic gonadotropin pregnancy test documented within 7 days prior to treatment. Have given written informed consent prior to any study-specific procedures.
+Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
+The participant, if female, is pregnant (confirmed by serum or urine beta-human chorionic gonadotropin [?-HCG] pregnancy test) or breastfeeding
+The participant, if female, is pregnant (confirmed by serum or urine beta-human chorionic gonadotropin [?-HCG] pregnancy test) or breastfeeding
+Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [B-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
+Negative urine or serum beta-human chorionic gonadotropin (?-HCG) pregnancy test within 7 days prior to the Cycle 1, Day 1 visit, for women of childbearing potential.