--- a +++ b/clusters/9knumclustersv2/clust_1047.txt @@ -0,0 +1,37 @@ +Females of childbearing potential (FCBP) must have negative pregnancy tests (sensitivity of at least mIU/mL) prior to initiating lenalidomide: the first pregnancy test must be performed within - days before and the second pregnancy test must be performed within hours before lenalidomide is prescribed for cycle (prescriptions must be filled within days) +FCBP must agree to use reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: ) for at least days before starting lenalidomide; ) while participating in the study; and ) for at least days after discontinuation from the study +Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or have or will have complete abstinence from heterosexual intercourse during the following time periods related to this study: ) while participating in the study; and ) for at least days after discontinuation from the study; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; FCBP must be referred to a qualified provider of contraceptive methods if needed; FCBP must have a negative serum pregnancy test at screening +Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or have or will have complete abstinence from heterosexual intercourse during the following time periods related to this study: ) while participating in the study; and ) for at least days after discontinuation from the study; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; FCBP must be referred to a qualified provider of contraceptive methods if needed; FCBP must have a negative serum pregnancy test at screening +Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques (Appendix D) during the length of lenalidomide maintenance therapy. +Females of childbearing potential (FCBP) must have negative pregnancy tests (sensitivity of at least mIU/mL) prior to initiating lenalidomide; the first pregnancy test must be performed within - days before and the second pregnancy test must be performed within hours before lenalidomide is prescribed for cycle (prescriptions must be filled within days) +FCBP must agree to use reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: ) for at least days before starting lenalidomide; ) while participating in the study; and ) for at least days after discontinuation from the study +Females of childbearing potential (FCBP) must have a negative serum and/or urine pregnancy test with a sensitive of at least mIU/mL within - days and again within hours prior to prescribe lenalidomide for cycle (prescriptions must be filled within days as required by Revlimid REMS) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by the Revlimid REMS program) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by Revlimid REMS) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also adhere to the scheduled pregnancy testing required in the Revlimid REMS; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Men must agree ) to use a latex condom during sexual contact with a female of childbearing potential (FCBP) even if they have had a vasectomy from the time of signing the informed consent form through days after the last dose of lenalidomide and ibrutinib; ) to not donate sperm during and after the study. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide through days and ibrutinib through days after the last dose of study drug. FCBP must also agree to ongoing pregnancy testing. +All post-menarchal females must have a negative beta-human chorionic gonadotropin (HCG); males and females of reproductive age and childbearing potential must use effective contraception for the duration of their participation; females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days and again within hours prior to prescribing lenalidomide for cycle and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) or a man who has sexual contact with a FCBP and is unwilling to use effective birth control for the duration of the study. +Effective contraception must be used by patients participating in lenalidomide therapy, and all patients must agree to counseling by a trained counselor every days about pregnancy precautions and risks of fetal exposure; females of childbearing potential (FCBP) must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least days before starting lenalidomide, during lenalidomide therapy, during dose interruptions, and for at least days following discontinuation of lenalidomide therapy; females of childbearing potential should be referred to a qualified provider of contraceptive methods, if needed; males receiving lenalidomide must agree to use a latex condom during any sexual contact with females of childbearing potential even if they have undergone a successful vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by Revlimid REMS) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or have or will have complete abstinence from heterosexual intercourse during the following time periods related to this study: while participating in the study and for at least days after discontinuation from the study; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; FCBP must be referred to a qualified provider of contraceptive methods if needed +Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or have or will have complete abstinence from heterosexual intercourse during the following time periods related to this study: ) while participating in the study; and ) for at least days after discontinuation from the study; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; FCBP must be referred to a qualified provider of contraceptive methods if needed +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide through days after the last dose of study drug; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy from the time of signing the informed consent form through days after the last dose of study drug; all patients must be registered in and must comply with all requirements of the Revlimid (lenalidomide) Risk Evaluation and Mitigation Strategy (REMS) program +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by RevAssist) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL prior to receiving treatment with lenalidomide, and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days and again within hours prior to prescribing lenalidomide for Cycle (prescriptions must be filled within days). FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods. +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL - days prior to therapy and repeated again within hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours of prescribing lenalidomide (prescriptions must be filled within days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours prior to the first prescription for lenalidomide (prescriptions must be filled within days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours of prescribing lenalidomide (prescriptions must be filled within days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, as least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days) and must either commit to continuous abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree not to father a child and agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by Revlimid REMS) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by RevAssist) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP)must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days and again within hours prior to prescribing lenalidomide prescriptions must be filled within days as required by Revlimid REMS and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days and again within hours prior to prescribing lenalidomide for cycle (prescriptions must be filled within days as required by Revlimid REMS) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL days prior to study enrollment and again within hours of prescribing lenalidomide (prescriptions must be filled within days) and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days and again within hours prior to starting Cycle of lenalidomide (prescriptions must be filled within days as required by RevAssist) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within - days prior to and again within hours of prescribing lenalidomide (prescriptions must be filled within days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least mIU/mL within days prior to and again within hours of prescribing lenalidomide (prescriptions must be filled within days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy +Negative urine pregnancy test in women of childbearing potential at screening and prior to prescribing lenalidomide. Females of childbearing potential (FCBP) must either commit to continued abstinence from heterosexual intercourse or begin acceptable methods of birth control for days prior to prescribing lenalidomide. Men must agree to use a latex condom during sexual contact with FCBP even if they have had a successful vasectomy, and must agree not to donate semen during study drug therapy and for a period of time after therapy. +Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or have or will have complete abstinence from heterosexual intercourse during the following time periods related to this study: ) while participating in the study; and ) for at least days after discontinuation from the study; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; FCBP must be referred to a qualified provider of contraceptive methods if needed +Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation