Male patients of childbearing potential must agree to use an adequate method of contraception as outlined in Section 6.4.5.3, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
Male subjects of childbearing potential must agree to use an adequate method of contraception; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of reproductive potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; NOTE: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
COHORT 1: Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
COHORT 2: Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female and Male subjects of childbearing potential must be willing to use an adequate method of contraception, starting with the first dose of study drug through 4 weeks after the last dose of study drug. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female and male subjects of childbearing potential must agree to use an adequate method of contraception, prior to study entry, for the duration of study participation, and 4 months after completion of pembrolizumab administration; contraception is required starting with the first dose of study medication through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female and male subjects of childbearing potential must agree to use an adequate method of contraception; contraception is required prior to study entry and for the duration of study participation and 4 months after completion of pembrolizumab administration; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female and male subjects of childbearing potential must agree to use an adequate method of contraception; contraception is required starting with the first dose of study medication through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects should agree to use an adequate method of contraception starting with D1 of HiDAC through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 60 days after the last dose of study therapy. \r\n* Note: Abstinence is acceptable if this is the preferred contraception for the participant.
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n*Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Men of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception; contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined - contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the date of consent through 120 days after the last dose of study therapy; NOTE: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects should agree to use an adequate method of contraception starting with the first dose of study medication until 120 days after the final dose of study medicine; abstinence is acceptable if this is the established and preferred contraceptive method for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception; contraception, for the course of the trial through 120 days after the last dose of trial drug; note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject; male subjects of childbearing potential must agree to use an adequate method of contraception; contraception, starting with the first dose of trial therapy through 120 days after the last dose of trial therapy
Patients able to father a child must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* NOTE: Abstinence is acceptable if this is the established and preferred method of contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception; contraception, starting with the first dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception; contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception. Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Persons able to father a child must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred method of contraception for the patient
Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy \r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male: use and adequate method of contraception with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception; contraception must be used starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: male subjects will be considered to be of non-reproductive potential if they have azoospermia (whether due to having had a vasectomy or due to an underlying medical condition)\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy; NOTE: abstinence is acceptable if this is the established and preferred contraception for the subject
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy\r\n* NOTE: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women; women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for >= 1 year; women must use an effective method of contraception from 14 days prior to randomization, throughout the treatment period, and for at least 6 months after the last dose of study treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception); hormonal-based methods (e.g., oral contraceptives) are NOT permitted as contraception
Men, even if surgically sterilized (i.e. status post-vasectomy), who are sexually active with WOCBP must agree to follow instructions for effective barrier contraception from the time of signing consent and until 4 months after last dose of protocol-indicated treatment; periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner) and withdrawal are not acceptable methods of contraception
For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of < 1% per year during the treatment period and for at least 3 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
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice two effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients must meet one of the following criteria:\r\n* Postmenopausal for at least 1 year prior to registration \r\n* Surgically sterile\r\n* Of childbearing potential and agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug\r\n* Of childbearing potential and agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject\r\nNOTE: periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Agree to use two reliable forms of contraception simultaneously or to practice complete abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg calendar, ovulation, symptothermal or post-ovulation methods] and withdrawal are not acceptable methods of contraception.) from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting CC-122; 2) while taking CC-122; 3) during dose interruptions; and 4) for at least 28 days after the last dose of CC-122 as specified in the Pregnancy Prevention and Risk Management Plan (PPRMP)
Practice complete abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg calendar, ovulation, symptothermal or post-ovulation methods] and withdrawal are not acceptable methods of contraception.) or agree to use a condom during sexual contact with a pregnant female or a FCBP for at least 12 months after the last dose of rituximab.
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.
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female subjects (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two (2) effective methods of contraception at the same time, or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) through 90 days after the last dose of maintenance therapy (see Section 2.6.2 for definition of postmenopausal).
Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy during the entire study treatment period and through 90 days after the last dose of study drug OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following protocol discontinuation, even if he has undergone a successful vasectomy\r\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception)
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients must meet one of the following:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR\r\n* If they are of childbearing potential:\r\n** Agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician. Effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation 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 150 days (5 months) after the last dose of study medication; examples of contraceptive methods with a failure rate of < 1% 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 childbearing potential (WOCBP) must agree to use an adequate method of contraception during the study and until 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment. Adequate methods of contraception include: total abstinence when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following study drug discontinuation, even if he has undergone a successful vasectomy\r\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
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 (>= 12 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 < 1% per year, during the treatment period and for at least 90 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 < 1% 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 < 1% per year; barrier methods must always be supplemented with the use of a spermicide
Persons of childbearing potential, agree to one of the following:\r\n* Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician. Effective methods of contraception are defined as those that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods]), and latex or non-latex condom with or without a spermicidal agent, diaphragm with spermicide; cervical cap with a spermicide; sponge with a spermicide
A woman of childbearing potential (WOCBP) is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months); female patients who are WOCBP must agree to practice:\r\n* 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* True abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* A WOCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting therapy with Revlimid; females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
Men must agree to practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following discontinuation of study therapy, even if he has undergone a successful vasectomy\r\n* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; this applies even if the subject practices true abstinence (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject; [periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]) from heterosexual contact; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
For women:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance (periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 3 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
Female patients who are of child-bearing potential (as defined above) should use enhanced methods of contraception from the time of screening until 90 days after the final dose of study drug; cessation of birth control after this point should be discussed with a responsible physician; acceptable methods of contraception include true abstinence in line with the preferred and usual lifestyle choice of the subject, tubal ligation, vasectomized partner, and methods listed in the table below; all methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by their male sexual partner for intercourse; periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Total abstinence from sexual relations for the duration of the treatment when applicable to the lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
true sexual abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of the trial, and withdrawal are not acceptable methods of contraception.
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients have to fulfill one of the following: \r\n* Be postmenopausal for at least 1 year before the screening visit, OR\r\n* Be surgically sterile, OR \r\n* If of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study treatment\r\n* Patients who are using oral contraceptives as a method of contraception, and are sexually active, should use another effective contraceptive method, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are NOT acceptable methods of contraception
Agree to practice true abstinence when this is line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation 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 150 days (5 months) after the last dose of study medication; examples of contraceptive methods with a failure rate of < 1% 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
Remain abstinent or use a condom as defined in Section 8.3.8.4.2, starting at the planned first dose of IP until 30 days following the last dose of IP. 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 subject. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.
has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months). True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
Refrain from semen or sperm donation while taking IP and for at least 90 days after the last dose of IP. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
Male subjects must: a. Practice true abstinence* or agree to the use of at least two physician-approved contraceptive methods throughout the course of the study and should avoid fathering a child during the course of the study for at least 3 months following the last dose of IP. * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation 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 (>= 12 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 < 1% 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 < 1% 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
Female patients who: \r\n* Are postmenopausal for at least 1 year before the screening visit, OR \r\n* Are surgically sterile, OR \r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy during the entire study treatment period and through 154 days after the last dose of lenalidomide (Revlimid) or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Men who are sexually active with women who are of childbearing potential must adhere to contraception for a period of 5 half-lives plus 90 days for a total of 7 months after their last dose of nivolumab
Female patients who: \r\n* Are postmenopausal for at least 24 months before the screening visit, OR\r\n* Are surgically sterile, OR \r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence or exclusively non-heterosexual activity when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Patients of childbearing or child fathering potential must use medically acceptable form(s) of birth control as stated within the pomalidomide Pregnancy Risk Minimization Plan, which includes abstinence, while being treated on this study; true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* Are of childbearing potential, \r\n** Agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients of childbearing potential [defined as all female patients ? 12 years old or who have reached menarche, whichever occurs first] must have both of the following: a. Agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study medication or for a longer period if required by regulations. i. True abstinence: When this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. ii. Acceptable contraceptive methods include: oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) including at least one barrier method. b. Have negative serum pregnancy test result at screening confirmed by negative urine pregnancy dipstick within 72 hours prior to first dose of Investigational Product (IP) (if serum test occurred > 72 hours from first dose); pregnancy test with sensitivity of at least 25 mIU/mL.
Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women; women of non-childbearing potential may be included without serum pregnancy test if they are either surgically sterile or have been postmenopausal for >= 1 year; fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the Investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent, during study treatment and for 90 days after the last dose of study treatment, AND \r\n* Must also adhere to guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must have a negative serum pregnancy test before initiation of study treatment and must also use highly effective methods of contraception while enrolled in the study. The use of highly effective contraception should continue for at least 14 days after the last dose of study treatment or until the last day of TFR/TFR-2, or for the duration of a monthly cycle of oral contraception, whichever is longer. Acceptable forms of highly effective contraception methods include: a. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception and male/female sterilization defined as:
If they were of childbearing potential must have: had a negative pregnancy test with a sensitivity of at least 25 mIU/mL within 10 to 14 days and again within 24 hours prior to starting Cycle 1 of lenalidomide; either agreed to practice true abstinence, when this was in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal were not acceptable methods of contraception.) OR begun 2 reliable methods of birth control (1 highly effective method and 1 additional effective method) at the same time, at least 28 days before starting study treatment through 90 days after the last dose of study treatment; and agreed to ongoing pregnancy testing AND must have also adhered to the guidelines of the RevAssist program (US participants), RevAid program (Canadian participants), iAccess program (Australian participants), RevMate program (Japanese participants) or The Lenalidomide Pregnancy Risk Minimisation Plan as outlined in the Study Manual (all other participants who were not using commercial supplies). Male patients, even if surgically sterilized (ie, status postvasectomy), who:
Agreed to practice true abstinence, when this was in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal were not acceptable methods of contraception.) OR
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR \r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception); if patient is female and of childbearing potential, she must have a negative serum beta human chorionic gonadotropin (3-HCG) test within 14 days prior to registration and consent to ongoing pregnancy testing during the course of the study
A highly effective method of contraception is defined as one that results in a low failure rate (ie, less than 1% per year) when used consistently and correctly. Acceptable methods of contraception are described in Table 4.2.1-1. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
Periodic abstinence (calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable.
Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (i.e., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
Female patients must be:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male subjects must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy. * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Note: Periodic abstinence (e.g, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Periodic abstinence (calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable.
Total abstinence (if this is the usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. (Subject must agree to use contraception should they become sexually active while on the study.)
If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception).
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception)
Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician; effective methods of contraception are defined as those, which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices); at the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation 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\r\n* For women who are not postmenopausal (>= 12 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 < 1% per year, during the treatment period and for at least 90 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 < 1% 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 < 1% 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 90 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
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Males or females of reproductive potential may not participate unless they have agreed to practice 1 highly effective and 1 additional effective (barrier) method of contraception at the same time during the entire study treatment period and through 4 months after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception
Women of childbearing age should avoid becoming pregnant while taking any mTOR inhibitor including MLN0128 (TAK-228)\r\n*Female patients must:\r\n** Be postmenopausal for at least 1 year before the screening visit, OR\r\n** Be surgically sterile, OR\r\n** If they are of childbearing potential, agree to practice 1 highly effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g., United States product insert [USPI], summary of product characteristics [SmPC], etc.;]) after the last dose of study drug, OR \r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; NOTE: periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* Male patients, even if surgically sterilized (i.e., status postvasectomy), must:\r\n** Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR \r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (NOTE: periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n** AND agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject\r\nNOTE: periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:\r\n* Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n* Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug
Non-pregnant; women of childbearing potential must have a negative pregnancy test (human chorionic gonadotropin [HCG] serum or urine) within 30 days prior to study registration and to be repeated if not done within 7 days of starting chemotherapy; female subjects participating in this study should avoid becoming pregnant, and male subjects should avoid impregnating a female partner; non-sterilized female subjects of reproductive age and male subjects should use effective methods of contraception through defined periods during and after study treatment as specified below\r\n* Female subjects must meet one of the following:\r\n** Natural postmenopausal before the screening visit defined as no menses at any time in the preceding 12 consecutive months, or\r\n** Prior bilateral oophorectomy or bilateral tubal ligation, or\r\n** If they are of childbearing potential, agree to practice two effective methods of contraception per discussion with the treating physicians from the time of signing of the informed consent form through three months after the last dose of study drug, or\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable contraception methods)\r\n* Male subjects, even if surgically sterilized (i.e., status post vasectomy) must agree to one of the following:\r\n** Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, or\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Negative serum pregnancy test done ? 7 days prior to registration, for women of childbearing potential only
Male subjects (even if surgically sterilized) must agree to one of the following: practice effective barrier contraception (see Section 2.6.4.1 for list of barrier methods), or practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of from the time of signing the informed consent through 90 days after last dose of maintenance therapy.
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condom should not be used together).
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient
Practice true abstinence or
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
Non-pregnant and non-lactating\r\n* Female patients who:\r\n** Are postmenopausal for at least 1 year before the screening visit, OR\r\n** Are surgically sterile, OR\r\n** If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Willing to follow strict birth control measures as suggested by the study\r\n* Female patients: if they are of childbearing potential, agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Willing to follow strict birth control measures;\r\n* Female patients: If they are of childbearing potential, agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 120 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), who: agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug.
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential:\r\n** Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), OR\r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status postvasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice 1 highly effective method and 1 additional (barrier) of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only and lactational amenorrhea are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status postvasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only and lactational amenorrhea are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Persons able to father a child: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
Female patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception; MUST have a negative serum or urine pregnancy test within 7 days of initiating protocol treatment unless prior hysterectomy or menopause (defined as 12 consecutive months without menstrual activity); patients should not become pregnant or breastfeed while on this study; should a woman become pregnant or suspect she is pregnant, she should inform her treatment physician immediately; male patients, even if surgically sterilized (ie, status post-vasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g. calendar, ovulation, symptothermal, post ovulation methods for the female partner] and withdrawal are not acceptable methods of contraception, or agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
Willing to follow strict birth control measures\r\n* Female patients: if they are of childbearing potential, agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment specific pregnancy prevention program, if applicable, OR \r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR \r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients must be:\r\n* Postmenopausal for at least 1 year before the screening visit, OR\r\n* Surgically sterile, OR\r\n* If they are of childbearing potential\r\n** Agree to practice 1 highly effective method and one additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy) must:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
Adequate contraception as follows:\r\n* For women:\r\n** Postmenopausal for at least 1 year before the screening visit, OR\r\n** Surgically sterile, OR\r\n** If they are of childbearing potential, agree to practice 1 effective method of contraception, and 1 additional (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g. United States Package Insert (USPI), Summary of Product Characteristics (SmPC), etc;]) after the last dose of study drug OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n* For men, even if surgically sterilized (i.e., status post-vasectomy), they must:\r\n** Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n** Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), who: agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, ad lactational amenorrhea are not acceptable methods of contraception); female and male condoms should not be used together; agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
For men, even if surgically sterilized (i.e., status post-vasectomy), they must:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception)\r\n* Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Sexually active subjects and their partners must agree to use medically accepted methods of contraception\r\n* For women:\r\n** Postmenopausal for at least 1 year before the screening visit, OR\r\n** Surgically sterile, OR\r\n** Agree to practice 1 effective method of contraception and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated by local labeling [e.g. United States product insert (USPI), summary of product characteristics (SmPC), etc.] after the last dose of study drug, OR\r\n**Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* For men:\r\n** Even if surgically sterilized (i.e., status post-vasectomy), they must agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n** Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
Patients who: a) are postmenopausal for at least 1 year before the screening visit, OR; b) are surgically sterile, OR; c) if they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR; d) agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception); male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following: e) agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR; f) agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together). Male participants, even if surgically sterilized (that is, status postvasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
Willing to follow strict birth control measures as suggested below\r\n* Female patients: if they are of childbearing potential (except if postmenopausal for at least 1 year before the screening visit, OR are surgically sterile), agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Willing to follow strict birth control measures as suggested by the study\r\n* Female patients: If they are of childbearing potential, must agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception)
Female patients who:\r\n* Are postmenopausal for at least 1 year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential:\r\n* Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)
Willing to follow strict birth control measures as suggested by the study\r\n* Female patients: If they are of childbearing potential, must agree to one of the following:\r\n** Practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)\r\n* Male patients: even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n** Agree to practice effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n** Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n** Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post vasectomy), have to either: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study treatment, OR \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Agree to practice true abstinence when this is line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.). Male participants, even if surgically sterilized (ie, status post vasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.). Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.).
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together). Male participants, even if surgically sterilized (that is, status postvasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), who: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR \r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice two effective contraception measures during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence or exclusively non-heterosexual activity when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
If they are of childbearing potential:\r\n* Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post vasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, and must also agree to ongoing pregnancy testing; must also adhere to the guidelines of the lenalidomide pregnancy prevention program
Male patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following: agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study treatment, OR \r\n* Must also adhere to guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female participants who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant
Male participants who agree to practice effective barrier contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: \r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Female patients who: are postmenopausal for at least 1 year, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 2 effective methods of contraception, from the time of signing the informed consent through 90 days after the last dose of study drug, OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception;) male patients, even if surgically sterilized, must agree to one of the following: agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR \r\n* Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception).
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence
Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence
For men, even if surgically sterilized (i.e., status post-vasectomy), they must:\r\n* Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together);\r\n* Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) Male participant, even if surgically sterilized (that is, status postvasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
Male patients, even if surgically sterilized (i.e., status postvasectomy) must agree to:\r\n* Practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR\r\n* Practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient;  NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* Not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug
Male patients, even if surgically sterilized (i.e. status post-vasectomy) must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR\r\n* Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception)
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participants. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.) Male participants, even if surgically sterilized (that is, status postvasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participants. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
total abstinence (if it is their preferred and usual lifestyle)
Female patients of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 6.4.5.3, for the course of the study through 120 days after the last dose of study medication. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
Female subjects of childbearing potential must be willing to use an adequate method of contraception; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subject of childbearing potential should have a negative serum pregnancy test performed during the screening period\r\n* Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
COHORT 1: Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication\r\n* NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
COHORT 2: Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication\r\n* NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male patients with WOCBP partners and female patients of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 7 months (male participants) or 5 months (female participants) after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
total abstinence (if it is their preferred and usual lifestyle)
Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential should be willing to use adequate method of contraception for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year; the two birth control methods can be two barrier methods or a barrier method plus a hormonal method to prevent pregnancy; subjects should start using birth control from the screening visit throughout the study period up to 120 days after the last dose of study therapy; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n*Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Male and female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception; contraception, for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Women of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication (note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject)
Male subjects must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication (note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject)
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
All individuals must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Female subjects of childbearing potential must be willing to use an adequate method of contraception; contraception should be used for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication.\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Total abstinence (if it is their preferred and usual lifestyle)
Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception; contraception, for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception; contraception must be used for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined - contraception, for the course of the study through 120 days after the last dose of study medication. Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception starting with the date of consent through 120 days after the last dose of study medication; NOTE: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Patients of reproductive potential must be willing to practice highly effective methods of contraception throughout the study and for 120 days after the last dose of study medication. Abstinence is acceptable if this is the usual lifestyle of the patient.
Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use adequate method of contraception; contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception; contraception, for the course of the study through 120 days after the last dose of study medication; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Total abstinence (if it is their preferred and usual lifestyle);
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female patients of childbearing potential and men receiving MK-3475 (pembrolizumab) who are sexually active with women of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of MK-3475 (pembrolizumab); note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient
Persons of childbearing potential must be willing to use an adequate method of birth control for the course of the study through 120 days after the last dose of study medication\r\n* NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred method of contraception for the patient
Female participants of childbearing potential must have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication); they should also be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential (FOCBP) must be willing to use an adequate method of contraception; contraception must be used for the course of the study through 120 days after the last dose of study medication\r\n* Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female and male subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Complete abstinence is only acceptable in cases where this is the preferred and usual lifestyle of the subject.
Complete abstinence is only acceptable in cases where this is the preferred and usual lifestyle of the subject.
Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use adequate methods of contraception for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year\r\n* NOTE: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use adequate method of contraception for the course of the study through 120 days after the last dose of study medication\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female subjects of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication; Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Female patients of childbearing potential must be willing to use adequate method of contraception - contraception, for the course of the study through 120 days after the last dose of study medication; patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year\r\n* Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject