Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
Female patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
Female patients who are pregnant are not eligible; Note: a pregnancy test is required for female patients of childbearing potential prior to study entry
Patients who are pregnant; pregnancy test is required for female patients of childbearing potential
Female patients who are pregnant are excluded; patients should not be pregnant or plan to become pregnant while on treatment; a pregnancy test prior to enrollment is required for female patients of childbearing potential
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes; hormonal contraceptives are not acceptable as a method of contraception; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to starting treatment)
Female patients are eligible to enter and participate in the study if they are of: a) Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who: i. has had a hysterectomy ii. has had a bilateral oophorectomy iii. has had a bilateral salpingectomy iv. is post menopausal (total cessation of menses for ? 1 year) b) Childbearing potential, has a negative serum pregnancy test at screening (within 7 days of the first investigational product administration), is not breast feeding, and uses highly effective contraception before study entry and throughout the study until 90 days after the last investigational product administration. Adequate contraception as recommended by the Clinical Trial Facilitation Group (CTFG)
Female research participants of childbearing age must not be pregnant as confirmed by a serum or urine pregnancy test within 1 week of start of treatment; participants must not be breast-feeding
If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception; (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001)
Female subjects must either be of non-reproductive potential, not breast-feeding or must have a negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1.
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients who have menstruated and are of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated)
Participant is pregnant, breast feeding or planning to become pregnant; (all participants of childbearing potential regardless of method of birth control must have a negative pregnancy test at baseline; a woman is considered not to be of childbearing potential is she has had a hysterectomy, bilateral oophorectomy, or if she is > 55 years of age with >= 2 years of amenorrhea)\r\n* Breastfeeding should be discontinued if the mother is treated with ACTOplus met XR
Pregnant and/or breastfeeding; a negative serum or urine pregnancy test is required at screening for all female patients of childbearing potential
Are pregnant or breast-feeding patients or any patient with childbearing potential not using adequate pregnancy prevention (site-specific criteria applying to Avera only)
Female patients of childbearing potential must have a negative serum pregnancy test within 3 days prior to taking their first dose of BGB324. Male patients and female patients of reproductive potential must practice highly methods of contraception throughout the study and for ? 3 months after the last dose of BGB324.
Female patients of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to initiating dosing. Male and female subjects with reproductive potential must agree to use acceptable contraceptive methods while on study therapy and for 12 week following their last dose of study medication.
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes; (females of childbearing potential must have a negative serum pregnancy test within 7 days prior to administration of axitinib)
Female patients of childbearing potential must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test within 14 days of registration.
Pregnant or lactating (female participant of childbearing potential must have negative serum or urine pregnancy test required within 7 days prior to start of treatment)
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test
Pregnant females are excluded; female subjects of childbearing potential must indicate to their physician that there is not a possibility of being pregnant at the time of enrollment or have a negative pregnancy test prior to initiation of radiation therapy
Female subjects of childbearing potential must have a negative pregnancy test at screening; childbearing potential is defined as: participants who have not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries and/or uterus)
Female subjects of childbearing potential must not be pregnant at screening; female patients must be either postmenopausal, free from menses for >= 2 years, surgically sterilized, or willing to use two adequate barrier methods of contraception to prevent pregnancy, or must agree to abstain from heterosexual activity throughout the study; female patients of childbearing potential must have a negative serum (beta human chorionic gonadotropin [?HCG]) or urine pregnancy test before receiving the first dose of cabozantinib or carfilzomib; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; women of reproductive potential will be counseled to use effective contraceptive\r\nmeasures to prevent pregnancy during treatment with either cabozantinib or carfilzomib; patients shall be advised not to take cabozantinib or carfilzomib treatment while pregnant or breastfeeding; if a patient wishes to restart breastfeeding after treatment, she will be advised to discuss the appropriate timing with her physician
Patients who are pregnant or breastfeeding, or expecting to conceive or father children within the projected timeframe of the study, starting from the time of the Screening Visit through 3 months (90 days) after the last OBP-301 administration. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at each visit before administration of OPB-301. A female not of childbearing potential is one who has undergone bilateral oophorectomy or who has had no menses for 12 consecutive months.
Negative urine or serum pregnancy test in females. Male and female patients with reproductive potential must use an approved contraceptive method if appropriate
Female patients of childbearing age must have a negative serum HCG test within 7 days of study enrollment, unless prior hysterectomy or menopause (defined as age ? 55 years and twelve consecutive months without menstrual activity). Female patients should not become pregnant or breast-feed while on this study.
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test within 14 days of registration
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial and for 8 weeks after stopping study drug, by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of EVE)
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception; (women of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to study entry; pregnancy test must be repeated if performed > 14 days before administration of MGCD516)
A female who is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 48 hours (Period 1) or 72 hours (Period 2), respectively, after the last dose of blinatumomab (Female subjects of childbearing potential should only be included in the study after a confirmed menstrual period and a negative highly sensitive urine or serum pregnancy test).
Female patients of childbearing potential who have a positive blood or urine pregnancy test at screening
Pregnancy or breast-feeding; female patients must be surgically sterile or be postmenopausal for two years, or must agree to use effective contraception during the period of treatment and 6 months after; all female patients with reproductive potential must have a negative pregnancy test (serum/urine) within 48 hours from starting the conditioning chemotherapy
Pregnant or lactating women; female study participants of reproductive potential must have a negative serum pregnancy test at enrollment
Female participants of childbearing potential have a negative urine or serum pregnancy test and must be willing to use an adequate method of contraception
Pregnant or lactating women; female subjects of childbearing potential must indicate to their physician that there is not a possibility of being pregnant at the time of enrollment or have a negative pregnancy test prior to the initiation of radiation therapy
Women who are pregnant or lactating; all female patients with reproductive potential must have a negative pregnancy test prior to day 1
Pregnant or breast-feeding female (women of childbearing potential [WOCBP], defined as not post-menopausal for 12 months or without previous surgical sterilization, must have a negative urine pregnancy test within 30 days of the first administration of domperidone and must either commit to continued abstinence from heterosexual intercourse or use an effective method of birth control during the course of the study)
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; barrier contraceptives must be used throughout the trial by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus and sorafenib)
A urine pregnancy test will be performed on each fertile premenopausal female prior to entry into the study; patients with childbearing potential must employ effective contraception during the radiation therapy
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
Pregnant or breast-feeding. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy.
If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding
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).
Female subject who is pregnant (as verified by urine test at time of screening) or lactating or of childbearing potential and not using acceptable methods of contraception.
Pregnancy or breastfeeding, or intention of becoming pregnant during the study. Female subjects must either be of non-reproductive potential or have a negative serum pregnancy test result within 14 days prior to initiation of study treatment
Female patients of childbearing potential have positive urine or serum pregnancy test no more than 7 days prior to starting study drug.
Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline; male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug; post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test (within 7 days prior to study registration)
Patients who are pregnant; a pregnancy test is required for female patients of childbearing potential
Women of childbearing potential only: negative serum pregnancy test done =< 7 days prior to registration; NOTE: female subjects who are pregnant or nursing are excluded from this study; there is no specific mitigation strategy for vismodegib toxicity; however, male patients should be made aware of it during the consent process; although this effect is expected to be reversible with discontinuation of dosing, long-term effects on male fertility cannot be excluded at this time
Pregnant or breast feeding; the agents used in this study have the potential to harm a fetus; radiation is a known teratogen; there is insufficient information regarding potential for fetal harm during immunotherapy at this time; biological females of childbearing potential must have a negative pregnancy test within 14 days of registration
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of EVEROLIMUS)
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of study drug)
Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes and continue use for 8 weeks after completing treatment; hormonal contraceptives are not acceptable as a sole method of contraception
A negative pregnancy test in female patients of childbearing potential; women must not be breast-feeding
Female subjects with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of therapy and on the first day of study drug administration.
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; two acceptable forms of contraceptives must be continued throughout the trial by either sex; hormonal contraceptives are not acceptable as a sole method of contraception (women of childbearing potential must have a negative serum pregnancy test within 7 days prior to day 1 of study drug)
Female patients of childbearing potential must have a negative urine or serum pregnancy within 72 hours before receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\r\n* Note: women of child-bearing potential must agree to use 2 methods of birth control, or be surgically sterile, or abstain from heterosexual activity beginning with the screening visit and for the duration of study participation, through 120 days beyond last dose of MK-3475 administration; patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year\r\n* Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to registration\r\n* Childbearing potential is defined as: participants who have not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus)
Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to registration and must implement adequate contraceptive measures during study treatment;
Pregnancy Status Female patients of childbearing potential, must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test.
Female who has been post-menopausal for more than one (1) year or female of childbearing potential agreeing to use a highly efficient method of contraception (i.e. a method with less than 1% failure rate [e.g. sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner or combined birth control pills]) Female of childbearing potential must have a negative from Screening until 90 days after last dose of INTUVAX and/or until completed sunitinib treatment whichever occurs later.blood pregnancy test at Screening, and if randomized to vaccination a negative blood or urine pregnancy test within one (1) day before each dose of Intuvax) and must not be lactating.
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; two acceptable forms of contraceptives must be continued throughout the trial by either sex and for 4 months (120 days) following last dose of either drug; hormonal contraceptives are not acceptable as a sole method of contraception; (women of childbearing potential must have a negative serum pregnancy test within 7 days prior to day 1 of study drug)
Female patients who are pregnant or breastfeeding. Female patients of childbearing potential must have a negative pregnancy test and agree to use adequate contraception for the duration of the trial.
Pregnant or breast-feeding patients are excluded; female patients of childbearing potential must have a negative serum or urine pregnancy test at the time of enrollment; in addition, female patients of childbearing potential must have negative pregnancy tests within 10 – 14 days prior to starting pomalidomide (can use enrollment pregnancy test if within the 10-14 day limit) AND again within 24 hours prior to initiation of pomalidomide; this protocol defines the following childbearing potential risk categories as:\r\n* Female child/young adult of childbearing potential as a female who has:\r\n** Achieved menarche and/or breast development, in Tanner stage 2 or greater\r\n** Has not undergone a hysterectomy or bilateral oophorectomy, or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\r\n* Note: amenorrhea following cancer therapy does not rule out childbearing potential
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated)
Female patients of childbearing potential must have a negative urine or serum pregnancy within 72 hours before receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\r\n* Note: women of child-bearing potential must agree to use 2 methods of birth control, or be surgically sterile, or abstain from heterosexual activity beginning with the screening visit and for the duration of study participation, through 120 days beyond last dose of MK-3475 administration; patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Female participants of childbearing potential must have a negative urine or serum pregnancy test and must be willing to use 2 adequate methods of contraception starting with the screening visit through 120 days after the last dose of pembrolizumab
Female patients of childbearing age must have a negative serum HCG test unless prior hysterectomy or menopause (defined as age ? 55 and twelve consecutive months without menstrual activity). Female patients should not become pregnant or breast-feed while on this study. Sexually active male and female patients should use effective birth control
Female subjects of childbearing potential must not be pregnant or breast-feeding; female subjects of childbearing potential must have a negative serum or urine pregnancy test; (pregnancy test must be repeated within 72 hours prior to the start of therapy)
Patients with reproductive potential (for example, females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy; female patients of childbearing potential must provide a negative pregnancy test (serum or urine) =< 14 days prior to treatment initiation
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes; (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of everolimus)
Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test; women of child-bearing potential must have a negative pregnancy test prior to the first dose of bevacizumab; male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following the discontinuation of bevacizumab; post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline; male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug; post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib
Pregnant females are excluded; female subjects of childbearing potential must indicate to their physician that there is not a possibility of being pregnant at the time of enrollment or have a negative pregnancy test prior to initiation of radiation therapy
Female patients who are pregnant or breastfeeding, or adults of reproductive potential who are not using effective birth control methods; adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes; women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to everolimus initiation
Female patients of childbearing potential must have negative serum or urine pregnancy test; patient must not be pregnant or breast feeding
Patients with reproductive potential (eg, females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy; female patients of childbearing potential must provide a negative pregnancy test (serum or urine) =< 14 days prior to treatment initiation
Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is not post-menopausal with a positive serum pregnancy test)
Pregnant or breast-feeding patients. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy
A woman of childbearing potential must have a negative serum or urine pregnancy test within 14 days before commencing treatment. Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously
Pregnant or lactating (female participant of childbearing potential must have negative serum or urine pregnancy test required within 7 days prior to start of treatment); male or female of reproductive potential has agreed to use effective contraception method for duration of study treatment
Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is post-menopausal with a positive serum pregnancy test
Female subjects who are not of childbearing potential and fertile female subjects of childbearing potential who agree to use adequate contraceptive measures who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of study treatment
Female subjects of childbearing age must have a negative urine HCG test unless prior hysterectomy or menopause (defined as age above 55 and twelve months without menstrual activity). Female subjects should not become pregnant or breast-feed while on this study. Sexually active male and female subjects should use effective birth control.
Pregnant or lactating (female participant of childbearing potential must have negative serum or urine pregnancy test required within 7 days prior to start of treatment)
Pregnant or lactating (female participant of childbearing potential must have negative serum or urine pregnancy test required within 7 days prior to start of treatment)
If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding.
Female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test
If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, then she must practice adequate contraception for 30 days prior to treatment administration, have a negative pregnancy test and continue such precautions for 2 months after completion of the treatment administration series.
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; if barrier contraceptives are being used, these must be continued throughout the trial by both sexes; hormonal contraceptives are not acceptable as a sole method of contraception (women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of EVEROLIMUS)
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods; adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes (women of childbearing potential [WOCBP] must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001)
If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate con-traception for 30 days prior to treatment administration, have a negative pregnancy test and continue such pre-cautions for two months after completion of the treatment administration series.
Pregnant or breast feeding patients. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy.
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
Female subject of childbearing potential is neither pregnant nor lactating and must have a negative pregnancy test at the screen visit and a negative pregnancy test before dosing. All female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective contraception (eg, implants, injectables, combined oral contraceptives, intrauterine device (IUD), sexual abstinence, vasectomy or vasectomized partner) for the duration of the study
Female participant of childbearing age must not be pregnant (confirmed by serum or urine pregnancy test within 1 week of eligibility) or lactating
All female patients of childbearing potential including those who are within 1 year of last menstrual period will be required to take a pregnancy test during screening, enrollment and at week 0, 4, 8 and 12
Individuals not pregnant at enrollment; female subjects of childbearing potential will undergo a pregnancy test prior to imaging
Individuals not pregnant at enrollment; female subjects of childbearing potential will undergo a pregnancy test prior to imaging
Pregnant or breastfeeding (if a female is of childbearing potential, and unsure of pregnancy status, a standard pregnancy test should be done)
Pregnancy (if a female is of childbearing potential—defined as a premenopausal female capable of becoming pregnant-a pregnancy test should be done)