[c09aa8]: / clusters / 9knumclustersv2 / clust_1942.txt

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Females of child-bearing potential (defined as a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy or has not been naturally post-menopausal for at least consecutive months) must:\r\n* Have a negative serum or urine pregnancy test obtained within hours prior to starting the investigational drug\r\n* Not be breastfeeding\r\n* Agree to use, and be able to comply with, highly effective contraception (failure rate less than % per year) without interruption while on study treatment plus half-lives of nivolumab (half-life up to days) plus days (duration of ovulatory cycle) for a total of weeks post treatment completion; complete abstinence is acceptable if it is in line with the preferred and usual lifestyle of the patient; period abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception; examples of non-hormonal contraceptive methods with a failure rate of < % per year include bilateral tubal ligation, male sterilization, hormonal implants, established and proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices; alternatively, two methods (e.g., two barrier methods from the options of diaphragm, cervical cap, vaginal sponge, and condom, or progesterone-only oral hormonal contraception where inhibition of ovulation is not the primary mode of action) may be combined to achieve a failure rate of < % per year; barrier methods must always be supplemented with the use of a spermicide
For women who are not postmenopausal (>= months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < % per year during the treatment period and for at least months after the last dose of study drug; abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal or postovulation methods) and withdrawal are not acceptable methods of contraception; examples of contraceptive methods with a failure rate of < % per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < % per year during the treatment period and for at least days after the last dose of study treatment. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (>= continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < % per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. The effects of atezolizumab on the developing human fetus are unknown and radiotherapy has known teratogenic effects so women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and months after completion of atezolizumab administration
Examples of contraceptive methods with a failure rate of < % per year include: bilateral tubal ligation; male partner sterilization; hormonal contraceptives that inhibit ovulation; hormone-releasing intrauterine devices; copper intrauterine devices.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < % per year during the treatment period and for at least days after the last dose of atezolizumab\r\n* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (>= continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)\r\n* Examples of contraceptive methods with a failure rate of < % per year include bilateral tubal ligation, male sterilization, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\r\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
Female and male participants of childbearing potential must agree to use an adequate method of contraception; contraception is required starting with the first dose of study medication through days ( months) after the last dose of study medication; examples of contraceptive methods with a failure rate of < % per year include bilateral tubal ligation, male sterilization, established and proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices; the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception
Women of child-bearing potential and men must agree to use adequate contraception as described below; 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\r\n* For women of childbearing potential:\r\n** Agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < % per year as outlined below\r\n** Female subjects of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days and again within hours prior to prescribing Revlimid for cycle (prescriptions must be filled within days as required by Revlimid risk evaluation and management strategy [REMS]) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking Revlimid; FCBP must also agree to ongoing pregnancy testing\r\n** A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (>= continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)\r\n** Examples of contraceptive methods with a failure rate of < % per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\r\n** The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* For men:\r\n** Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\r\n** With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < % per year as noted below; men must refrain from donating sperm during this same period\r\n** With pregnant female partners, men must remain abstinent or use a condom as noted below to avoid exposing the embryo\r\n** The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception
For all women of childbearing potential, a negative pregnancy test must be obtained at the baseline visit before starting study treatment; for women who are not postmenopausal (>= months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < % per year, during the treatment period and for at least days after the last dose of study drug\r\n* Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Examples of contraceptive methods with a failure rate of < % per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices; alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < % per year; barrier methods must always be supplemented with the use of a spermicide
For women who are not postmenopausal (>= months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < % per year during the treatment period and for at least months after the last dose of study drug; abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception; examples of non-hormonal contraceptive methods with a failure rate of < % per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices; alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < % per year; barrier methods must always be supplemented with the use of a spermicide
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use of contraceptive methods that result in a failure rate of < % per year during the treatment period and for at least days after the last study treatment. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (>= continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < % per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < % per year during the treatment period and for days after tazemetostat discontinuation\r\n* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (>= continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)\r\n* Examples of contraceptive methods with a failure rate of < % per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\r\n* Female subjects who use hormonal contraceptives should use an additional barrier method of birth control while on study treatment and for days after discontinuation of study treatment\r\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception starting with the first dose of study medication through days ( months) after the last dose of study medication; examples of contraceptive methods with a failure rate of < % per year include bilateral tubal ligation, male sterilization, established and proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (>= continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus); examples of contraceptive methods with a failure rate of < % per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices; the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
Examples of non-hormonal contraceptive methods with a failure rate of < % per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices; the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < % per year during the treatment period and for at least days after the last dose of venetoclax or months after the last dose of rituximab, whichever is longer\r\n* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (< continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus); examples of contraceptive methods with a failure rate of < % per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\r\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < % per year during the treatment period and for at least days after the last dose of venetoclax or months after the last dose of rituximab, whichever is longer\r\n* A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (>= continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)\r\n* Examples of contraceptive methods with a failure rate of < % per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices
Willingness to use adequate contraception to avoid pregnancy or impregnation for the duration of study participation; Note:\r\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation\r\n* For men and women who are not postmenopausal (i.e., >= months of non-therapy-induced amenorrhea, confirmed by follicle stimulating hormone [FSH], if not on hormone replacement) or surgically sterile (vasectomy in males or absence of ovaries and/or uterus in females), agreement to remain abstinent or use highly effective or combined contraceptive methods that result in a failure rate of < % per year during the treatment period and at least through week after last dose\r\n* Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n* Examples of contraceptive methods with an expected failure rate of < % per year include male sterilization and hormonal implants; alternatively, proper use of combined oral or injected hormonal contraceptives and certain intrauterine devices or two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < % per year (barrier methods must always be supplemented with the use of a spermicide)\r\n* Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately\r\n* Should a female partner of a male study participant become pregnant while the male participant is on study, the male participant should inform his study physician immediately
For all women of childbearing potential, a negative pregnancy test must be obtained at the baseline visit before starting study treatment\r\n* For women who are not postmenopausal (>= months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < % per year, during the treatment period and for at least days after the last dose of study drug\r\n** Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception\r\n** Examples of contraceptive methods with a failure rate of < % per year include tubal ligation, male sterilization, hormonal implants, established, proper use of combined oral or injected hormonal contraceptives, and certain intrauterine devices; alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of < % per year; barrier methods must always be supplemented with the use of a spermicide\r\n* For men: agreement to remain abstinent or use a barrier method of contraception (e.g., condom) during the treatment period and for at least days after the last dose of study drug and agreement to refrain from donating sperm during this same period\r\n** Men with a pregnant partner must agree to remain abstinent or use a condom for the duration of the pregnancy\r\n** Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception