[c09aa8]: / clusters / ordered9kclusters / clust_984.txt

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Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; women of child-bearing potential and their partners should agree to use two (2) highly effective forms of contraception throughout study participation and for at least one (1) month after the last dose of olaparib; male study participants should avoid fathering a child or donating sperm during the study and for three (3) months after the last dose of olaparib
Women of child-bearing potential (WCBP) must agree to use a medically accepted form of pregnancy prevention for the duration of study treatment
Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during the treatment portion of the study and for 4 months after completion of hetIL-15 administration.
Men with child bearing potential are required to use an effective means of contraception
Agree that during the trial, men will not father a child, and women cannot be or become pregnant. Participants must be of non-child bearing potential or agree to use one highly effective or combined contraceptive methods that result in a failure rate of <1% per year during the treatment period and at least through week 12 after last dose;
Of non-child-bearing potential (surgically sterilized or at least 2 years postmenopausal); or
Women of child-bearing potential using hormonal contraception, unless an additional contraception method is also used according to the Mekinist® label. Additional exclusion criteria for Combination arm PDR001+EGF816
If female of child bearing potential, must not be lactating and must have a negative pregnancy test (blood or urine, at the discretion of the investigator) prior to enrollment and use effective contraception during study participation. Women should continue effective contraception for 3 months following last dose of TB-403.
Female patients of child-bearing potential and male patients must agree to use adequate contraception
Women of child bearing potential and men must agree to use contraception prior to study entry and through day 100 post HCT.
Women of child-bearing potential (WOCBP) must agree to use an effective method(s) of contraception during treatment and during the post treatment follow-up period
Women of child-bearing potential (WOCBP) not practicing an effective method(s) of contraception.
Female participants of child-bearing potential must be willing to use effective contraception starting with the screening visit through 120 days after the last dose of study therapy
Females of child bearing potential and male partners of female patients must agree to use adequate contraception during the study and for 6 months after their last dose of study drug.
For men and women of child-bearing potential, willing to use adequate contraception (e.g., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study.
Female patients of child-bearing potential and male patients with sexual partners of child-bearing potential who are unwilling to follow strict contraception requirements before entry and throughout the study, up to and including the 30-day non-treatment follow-up period. Examples of acceptable contraception methods include:
Females must not be pregnant or lactating. Women of child-bearing potential must use a highly effective method of contraception throughout their study participation and for at least 6 months following the last dose of study drug.
Males must be surgically sterile, abstinent, or if engaged in sexual relations with a female of child-bearing potential, must be willing to use a highly effective method of contraception throughout their study participation and for at least 6 months after the last dose of study drug.
If of child-bearing pIf of child-bearing potential, subject must use an adequate method of contraception consisting of two-barrier method or one barrier method with a spermicide or intrauterine device. Both females and male subjects with female partners of child-bearing potential must agree to use an adequate method of contraception for 2 weeks prior to screening, during, and at least 4 weeks after last dose of study medication. Female subjects must have a negative serum or urine pregnancy test within 72 hours prior to start of study medication.
Women with child bearing potential and men with reproductive potential must be willing to practice acceptable methods of contraception
Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation
Women of child-bearing potential (WoCBP) may be included only if acceptable contraception is in place for two weeks before study entry, for the duration of the treatment with the study drug, and for 2 months after the last dose of AZD1775; male patients who are involved in the study must agree to avoid procreative and unprotected sex (i.e., by using acceptable forms of contraception) and must not donate sperm during the study and for 3 months after the last dose of AZD1775; where the female partner is pregnant or not using effective birth control, men should be advised to abstain while in the study and for 3 months after the last dose of AZD1775; female partners, who are of child-bearing potential, of men participating in clinical studies of AZD1775 will also be required to use effective contraceptive measures while their partner is on study drug and for 3 months thereafter; male patients will be advised to arrange for the freezing of sperm samples prior to the start of the study should they wish to father children while on AZD1775 or during the 3 months after stopping AZD1775
Pregnancy (positive pregnancy test) or lactation. Use of effective means of contraception (men and women) in subjects of child-bearing potential
In females with childbearing potential, or men with partners of child bearing potential, willingness to use adequate contraception for a minimum duration of 155 days in females and 215 days in males, after last dose of nivolumab
Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study
Women of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the first dose of study treatment and agree to use appropriate highly effective methods of contraception, during the study and for 5 months following completion of study treatment;\r\n* A “woman 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; in addition, women under the age of 62 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL\r\n* Female subjects: women of child bearing potential are expected to use one of the highly effective methods of contraception\r\n* Male subjects: male subjects must inform their female partners who are women of child bearing potential of the contraceptive requirements and are expected to adhere to using contraception with their partner; female partners of male subjects, who are women of child bearing potential, are expected to use one of the highly effective methods of contraception; in addition, male subjects are expected to use a condom
Men and women of child-bearing age need to commit to using two methods of contraception simultaneously to avoid pregnancy.
Subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 150 days after the last dose of study therapy (for women of child-bearing potential) or 210 days after the last dose of study therapy (for men who have partners of child-bearing potential)
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
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.
Women of child-bearing potential (those who have had a menstrual cycle within the last year and have not had a tubal ligation or surgical removal of both ovaries and/or hysterectomy) must agree to abstain from vaginal intercourse and continue contraception for 3 weeks after discontinuation of study treatment
Sexually active women of child-bearing potential must be willing to use effective contraception through month 7 of the study
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
Negative urine or serum pregnancy test result for females of child bearing potential; females of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 23 weeks after the last dose of study drug; males who are the sexual partners of a female of child-bearing potential must use any contraceptive method with a failure rate of less than 1% per year for the duration of study participation and for a period of 31 weeks after the last dose of study drug; these periods of required use of contraception have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that females of child-bearing potential use contraception for 5 half-lives plus 30 days and males who are the sexual partners of females of child-bearing potential use contraception for 5 half-lives plus 90 days; \r\n* Females must not be breast-feeding\r\n* Females of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab\r\n* A female of child-bearing 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 female over 45 in the absence of other biological or physiological causes; in addition, females under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL\r\n* Females who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic males do not require contraception\r\n* Should a female of child-bearing potential become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
Women of child-bearing potential must agree to use 2 reliable methods of contraception beginning 4 weeks prior to the initiation of treatment, during therapy, and for at least 4 weeks after the last drug administration.
Women of child-bearing potential, defined as all women older than age 50 and anovulatory for 12 months, unless they are using highly effective methods of contraception during dosing and for 30 days after study treatment
A negative pregnancy test (if female of child bearing potential); for men and women of child-producing potential, willingness to use effective contraceptive methods during the study
Women of child bearing potential (WOCBP) must use a reliable form of contraception during the study treatment period and for up to 12 weeks following the last dose of study drug; in order for a woman to be determined not of child-bearing potential, she must have >= 12 months of non-therapy-induced amenorrhea or be surgically sterile
Meets one of the following criteria: Is post-menopausal, or, Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for four months after stopping medication.
For men and women of child-bearing potential, willing to use adequate contraception
Women of child bearing potential or sexually active fertile men with partners who are women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 120 days after the last dose of investigational product
Women of child-bearing potential must have negative serum pregnancy test and use accepted highly effective methods of birth control throughout the study and for 90 days after dosing and must agree to use effective contraception.
Patients of child bearing potential or with partners of child-bearing potential must agree to practice recommended contraceptive methods to prevent pregnancy during treatment and for 5 months after the last dose of nivolumab for women, and 7 months after the last dose of nivolumab for men, and 6 months after the last dose of bevacizumab for subjects receiving bevacizumab
Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of 3 months after study treatment
Women of child-bearing potential, unless they are using highly effective methods of contraception
If the patient is a woman of child-bearing potential, the patient and their sexual partner must agree to practice effective contraception
Men or women of childbearing potential who are unwilling to employ adequate contraception\r\n* NOTE: patients unwilling or unable to do any of the following are also excluded:\r\n** Men must agree to use a latex condom during sexual contact with a female of child-bearing potential even if they have had a successful vasectomy\r\n** Women of child bearing potential must agree to use 2 methods of reliable contraception simultaneously\r\n** All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
Patients of child bearing potential who are sexually active must agree to the use of two highly effective forms of contraception from the time of informed consent through 6 months after last dose of study drug(s)
Sexually active women of child-bearing potential must agree to use two forms of contraception prior to study entry and for the duration of study participation. A pregnancy test is required prior to study enrollment and monthly while on treatment with indoximod for all women of child- bearing potential. Also men should be discouraged from fathering children while on treatment.
Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use 2 highly effective methods of contraception while taking study treatment and for 90 days after the last dose of study treatment.
Women of child bearing potential who refuse or are not able to use a highly effective method of contraception as defined in the study protocol.
Negative serum beta-HCG in females, and use of effective contraception in males and females of child-bearing potential, is required
Positive urine pregnancy test and/or breastfeeding; if a woman of child bearing potential or sexually active male, patient must be willing to use effective contraception throughout their participation in the treatment phase of the study
Pregnancy (positive pregnancy test) or lactation; use of effective means of contraception (men and women) in subjects of child-bearing potential
Subjects unwilling to use contraceptives if they have sexual intercourse with a female partner of child-bearing potential while receiving treatment on this study
Women and men of child producing potential must agree to use highly effective means of contraception during study participation, and for at least 30 days after the last administration of study medication.
Women of child bearing potential must have a negative pregnancy test (blood or urine) within 14 days before treatment and agree to use appropriate contraception from study screen through the duration of the trial; men must agree to use appropriate contraception from study screen through the duration of the trial
Women of child bearing potential not willing to use an effective contraceptive measure while on study
Women of child bearing potential must have a negative pregnancy test (blood or urine) within 14 days before treatment and agree to use appropriate contraception from study screen through the duration of the trial; men must agree to use appropriate contraception from study screen through the duration of the trial
Use of effective means of contraception (men and women) in subjects of child-bearing potential
Eligibility criteria specific to the CC-115 arm:\r\n* Participants must be willing and able to provide written informed consent for the CC-115 arm of the INSIGhT trial\r\n* Women of child bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from date of initial dose and for 28 days following the last dose of CC-115; men (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in sexual activity with a woman of child bearing potential from date of initial dose and for 28 days following the last dose of CC-115
All sexually active subjects (males and females of child-bearing potential) agree to use 2 effective methods of contraception for the duration of the study
Patients of child bearing potential should practice effective methods of contraception
Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non-sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and abstinence.
Women of child-bearing potential and men must agree to use adequate contraception prior to the start of treatment, for the duration of treatment, and for 5 months after last dose of study treatment
Estimated life expectancy of at least 8 weeks; 7. Eastern Cooperative Oncology Group (ECOG) performance status ? 2; 8. Significant toxicities incurred as a result of previous anti-cancer therapy resolved to ? Grade 1 (NCI-CTCAE version 4.03); 9. Acceptable laboratory values at screening; 10. Male patients must agree to use an adequate and medically accepted method of contraception throughout the study and for at least 3 months after if their sexual partners are women of child bearing potential (WOCBP).
For men and women of child-bearing potential, willing to use adequate contraception (i.e., latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months afer stopping ceritinib treatment.
Male or female of child-bearing potential must agree to use adequate contraceptive methods
Pregnancy or lactation; females of child bearing potential must use adequate contraceptive methods;
Willingness to use effective contraception (both males and females of child-bearing potential) throughout the study and for at least 2 months after study treatment.
Teratogenic effects of cenersen are unknown, women of child-bearing potential & men must agree to use adequate contraception prior to study entry & for the duration of study participation.
Negative urine or serum pregnancy test for females of child bearing potential within 7 days prior to registration\r\n* Females of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 23 weeks after the last dose of study drug; males who are the sexual partners of a female of child-bearing potential must use any contraceptive method with a failure rate of less than 1% per year for the duration of study participation and for a period of 31 weeks after the last dose of study drug; these periods of required use of contraception have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that females of child-bearing potential use contraception for 5 half-lives plus 30 days and males who are the sexual partners of females of child-bearing potential use contraception for 5 half-lives plus 90 days\r\n* Females must not be breast-feeding\r\n* Females 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 24 hours prior to the start of nivolumab\r\n* A female of child-bearing 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 female over 45 in the absence of other biological or physiological causes; in addition, females under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL\r\n* Females who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and azoospermic males do not require contraception\r\n* Should a female of child-bearing potential become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
Male or female, age 18 or above, who agree to use barrier contraception throughout the study. Females of child-bearing potential must be non-pregnant and non-lactating throughout the study.
Pregnant women or women who are of child bearing age who are not willing to use two (2) forms of contraception during treatment with enzalutamide and for six (6) months after treatment
Men must use adequate methods of contraception during and at least 3 months after treatment if engaging in sexual activity with a female of child bearing age
Women of child-bearing potential defined as all women physiologically capable of becoming pregnant who are unwilling to use highly effective methods of contraception throughout the study and 15 days after study drug discontinuation
Women of child bearing potential who are unwilling to use effective contraception for the duration of the study drug administration and 6 months after final dose of drug is administered;
Women of child-bearing potential MUST have a negative serum human chorionic gonadotropin (HCG) test unless prior hysterectomy or menopause (defined as 12 consecutive months of amenorrhea); subjects are considered not to be of child-bearing potential if they are surgically sterilized or post-menopausal (>=50 years of age and has not had menses for greater than 1 year or with serum follicle stimulating hormone (FSH) in the menopausal range will be considered postmenopausal); subjects should not become pregnant or breastfeed while on this study; sexually active subjects of child bearing potential must agree to use contraception for the duration of study participation and for 5 months after the last dose of ipilimumab or nivolumab
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and continuing (23 weeks for females, 31 weeks for males) after the last dose of nivolumab
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
FOR PDX-GUIDED THERAPY THROUGH ONGOING TRIALS AT MD ANDERSON OR OFF-PROTOCOL WITH STANDARD OF CARE (PART 2): Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. Men must agree not to father a child and agree to use a condom if his partner is of child-bearing potential.
Female subject of child-bearing potential is not willing to use, in combination with her partner, 2 methods of highly effective contraception during treatment and for 5 months after the end of treatment
Women of child bearing potential and men must agree to remain abstinent or use adequate contraception (failure rate < 1%) for the duration of study and for 90 days after the completion of the therapy
Women of child-bearing potential (WOCBP) must agree to use adequate contraception when sexually active; patients should continue contraception for 6 months after finishing study drug
Female patients of child-bearing potential or male patients with partners of child-bearing potential who are unwilling to follow strict contraception requirements before entry and throughout the study, up to and including the 30-day non-treatment follow-up period.
Women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
Women of child-bearing potential must agree to use adequate contraception, defined as complete abstinence from intercourse with men or two methods
Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
Pregnant (positive pregnancy test) or lactating women will be excluded from the study; also, unwillingness to use effective means of contraception in subjects with child-bearing potential will be excluded from the study; women of child-bearing potential must use two forms of contraception (i.e., barrier contraception and one other method of contraception) at least 4 weeks prior to study entry, for the duration of study participation
Females of child-bearing potential who are pregnant or lactating or who are not using approved contraception
Pregnant (positive pregnancy test) or lactating; unwillingness to use effective means of contraception in subjects with child-bearing potential
Women of child-bearing potential unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the study treatment.
Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants must agree to use highly effective methods of contraception for at least 12 months following CTL019 infusion and until CAR T cells are no longer present by PCR on two consecutive tests
Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
If the subject is a woman of child-bearing potential or man who is sexually active with woman of child-bearing potential, the subject agrees to use adequate contraception from signing of the ICF, for the duration of study participation; and for 23 weeks after the last dose of IMP for women or 31 weeks after the last dose of IMP for men;
Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CTL019 infusion.
Patients of child-bearing potential must agree to use a medically approved contraception method until at least six weeks after the last study drug administration.
For women of child-bearing potential and for men with partners of child-bearing potential, subject must agree to take contraceptive measures for duration of treatments and 6 months after the last dose of BEV.
Women of child-bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
Patients with child bearing potential must agree to use adequate contraception
Women of child bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
Males with female partners of child bearing potential must agree to use protocol defined methods of contraception (see below) and agree to refrain from donating sperm for the duration of the study
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after completion of dosing.
Use of an effective means of contraception in subjects of child-bearing potential
Women of child-bearing potential and male subjects with female partners of child-bearing potential must be willing to use acceptable methods of contraception to avoid pregnancy (for example, oral, injectable, or implantable hormonal contraceptive, tubal ligation, intra-uterine device, barrier contraceptive with spermicide, or vasectomized partner) beginning before the first infusion of G-202 and for 3 months after the last infusion of G-202
Men who are sexually active with women of child bearing potential must agree to use a condom from screening through 7 months after the last dose of study treatment (including nivolumab single agent).
Must not be pregnant or breastfeeding; female patients who are sexually active and of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients who are sexually active must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; for both male and female patients who are sexually active, effective methods of contraception must be used throughout the study and for three months following the last dose; abstinence is an acceptable form of contraception
Surgically sterile patients or patients of child-bearing potential who agree to use highly effective methods of contraception during study dosing and for 6 months after last dose of study drug
Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after treatment completion
Females of child-bearing potential must agree to use adequate contraception and for 3 months after the last dose of study drug
Women of child-bearing potential should use reliable methods of contraception from the time of screening until 6 months after discontinuing study treatment; acceptable methods of contraception include tubal ligation, tricycle combined oral or transdermal contraceptives, copper-banded intra-uterine devices and vasectomized partner; hormonal contraceptives should be combined with a barrier method of contraception; 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 child-bearing potential must have a negative pregnancy test prior to entry; male patients should use reliable methods of contraception such as barrier contraception i.e. condoms during sexual activities with women of child-bearing potential and refrain from sperm donation during the trial and for a washout period of at least 6 months; if male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of study treatment
Women of child bearing potential and men must agree to use adequate contraception during the study and for 6 months after their last dose of study drug.
Pregnancy, or unwillingness to use contraception if they have child bearing potential
Patient is of child bearing potential and is not willing to use, in combination with her partner, two highly effective methods of contraception or abstinence during treatment and for 5 months after the end of treatment
Child bearing potential: In this patient population, this pertains to the ability to conceive a child; eligible patients already have received prostatectomy, and therefore this risk is not applicable
Female subjects who are postmenopausal for at least 1 year prior to screening. For women of child-bearing potential agree to practice 2 effective methods of contraception, or agree to practice true abstinence
Men of child bearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation
Women with child bearing potential and men with reproductive potential must be willing to practice acceptable methods of contraception
If a female of child bearing potential, willing to use adequate contraception (defined as double-method contraception, e.g. oral contraceptive usage by subject and condom by partner); non-child bearing potential is defined as being at least 2 years post-menopausal or being surgically sterile
Women of child-bearing potential must use highly effective contraception during the study and for 84 days after the study drug infusion.
Women of child bearing potential (WCBP), must agree to use 2 contraceptive methods
Sexually active females of child bearing potential and males must agree to use effective contraception for the duration of the transplant period
Females: pregnant or breast feeding and if of child bearing potential (e.g. female of childbearing age that has not been amenorrheic for at least 12 consecutive month or surgically sterilized) not willing to use effective contraception
Women of child-bearing potential and men must agree to use adequate contraception
Pregnancy (positive pregnancy test) or lactation- breast feeding; lack of effective means of contraception (men and women) in subjects of child-bearing potential
Pregnancy (positive pregnancy test) or lactation; (an effective means of contraception [men and women] in subjects of child-bearing potential must be used)
Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended.
Women of child-bearing potential and men must agree to use adequate contraception
Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
Pregnant or lactating females will be excluded from this trial; patients of child-bearing potential must use an effective form of contraception while on study
Women of child-bearing potential and sexually active men must agree to use adequate contraception prior to study entry for six months following duration of study participation
Pregnancy or breast-feeding (participants of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
Barrier contraceptive precautions are to be used throughout the trial by all study participants of child bearing potential.
Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
Pregnancy: Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation; a woman of child-bearing potential is defined as a woman who has not been naturally post-menopausal for at least 12 consecutive months or with no previous surgical sterilization; a negative pregnancy test result will be required before any study drug is given
Patients with child-bearing potential will agree to use contraception while on study and for 30 days from the date of the last therapy on protocol
Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or is of child-bearing potential; female subjects of child-bearing potential must agree to abstain from sexual activity or to use 2 medically approved contraceptive measures/regimens from the time of signing the informed consent form through 3 months after the treatment period
lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
Male and female patients of child-bearing potential unwilling to use effective means of contraception
Male and female patients of child-bearing potential unwilling to use effective means of contraception
Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study.
Subject is of child bearing potential and is not willing to use, in combination with her partner, 2 highly effective methods of contraception or abstinence during treatment and for 5 months after the end of treatment
Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of 6 months after study treatment.
Women of child-bearing potential and men must agree to use adequate contraception.
Pregnancy or lactation; patients of child bearing age must agree to use adequate contraception
Pregnant or nursing (lactating) women confirmed by a positive hCG laboratory test\r\n* Women of child-bearing potential unless they are using highly effective methods of contraception throughout the study and for 30 days after study drug discontinuation
Women of child bearing potential not willing to use an effective contraceptive measure while on study
Women of child-bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study.
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and must agree to practice acceptable contraceptive methods; men must agree not to father a child and agree to use a condom if his partner is of child bearing potential
Women of child-bearing potential are required to use effective contraception throughout the study period. Effective contraception methods include:
Subjects with child-bearing potential agree to use effective means of contraception
Women of child bearing potential and their partners must use an acceptable method of contraception while enrolled on this study, and for a period of 3 months following study drug treatment. Patients unwilling or unable to follow this guideline will be excluded. Investigators should follow their Institutional standard regarding acceptable methods of contraception.
women of child-bearing potential and male patients with sexual partners of child-bearing potential unwilling to use highly effective methods of contraception during dosing and for a specified duration after stopping study treatment
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study for 60 days after study drug discontinuation
Male and female patients of child bearing potential must use an effective contraceptive method during the course of the study
Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a female of child-bearing potential
Women of child-bearing potential must use an effective form of contraception during study and for at least 6 months after completion of study treatment
Women of child-bearing potential and men must agree to use adequate contraception
Patients who are pregnant or nursing; subjects of child-bearing age have to use effective means of contraception
Female subject of child bearing potential is not willing to use two methods of highly effective contraception during treatment and for 5 months after the end of treatment
Women of child-bearing potential unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the study treatment.
Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening; male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential throughout the study and for three months following the last dose of selinexor
Women of child bearing potential agree to use effective contraception during therapy and for 4 months after completion of therapy
Females of child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding must be willing to use an effective contraceptive measure until 30 days after the last dose of eltrombopag; males who have had sexual contact with female of child-bearing potential must be willing to use contraceptive techniques until 30 days after the last dose of eltrombopag
Child: child understands English
Pregnancy (positive pregnancy test) or lactation; use of effective means of contraception (men and women) in subjects of child-bearing potential
Female subject of child bearing potential must be willing to use, in combination with her partner, 2 forms highly effective contraception during treatment and for 1 month after the end of treatment
Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation
Female subject of child bearing potential is not willing to use highly effective contraception during treatment and for 5 months after the end of treatment (see section 6.3)
Patients of child bearing potential or with partners of child-bearing potential must agree to practice recommended contraceptive methods to prevent pregnancy during treatment and for 1 month after the last dose of AED for women and men
Patients who are not practicing adequate contraception are ineligible if they are of child bearing potential
Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
Women of child-bearing potential willing to practice 2 forms of contraception, one of which must be a barrier method until at least 30 days after the last dose of rapamycin
Patients who are not practicing adequate contraception if the participants are of child bearing potential
Women of child-bearing potential and men with reproductive potential, if they are unwilling to use adequate contraception while on study therapy and for 3 months thereafter
Participants of child-bearing age must use appropriate contraception (barrier, hormonal or post-menopausal) until one month after study medication ends
Of child-bearing age with intact reproductive organs
Use of an effective means of contraception in women of child-bearing potential
Women of child-bearing potential who are unable or unwilling to use an acceptable method of contraception.
must be willing to use appropriate contraception if of child-bearing potential
For women of child-bearing potential and for men with partners of child-bearing potential, patient must agree to take contraceptive measures for duration of treatments and for one month after last study treatment