WOCBP who are unwilling or unable to use an acceptable method of avoiding pregnancy for the entire study period
Women of childbearing potential (WOCBP), who:\r\n* Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 8 weeks after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding
Women who\r\n* Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study therapy\r\n* Have a positive pregnancy test at baseline\r\n* Are pregnant or breastfeeding
Men and women who:\r\n* Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or women who:\r\n** Have a positive pregnancy test at baseline, or\r\n** Are pregnant or breastfeeding
Male subjects who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 90 days after the last dose of GC4419 are excluded.
Pregnant and breastfeeding women are excluded; women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded; this applies to any woman who has not experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months); male subjects must also agree to use effective contraception for the same period as above
WOCBP who are unwilling or unable to use an acceptable method to minimize the risk of pregnancy for the entire study period and for at least 23 weeks after the last dose of investigational product
Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy after the receipt of brachytherapy; male subjects must also agree to use effective contraception during the treatment period and until 1 year after the completion of brachytherapy
Pregnant and breastfeeding women are excluded; women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded; this applies to any woman who has not experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months); male subjects must also agree to use effective contraception for the same period as above
Women who:\r\n* Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding
Women of childbearing potential (WOCBP), defined above, who:\r\n* Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 26 weeks after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding
Sex and reproductive status:\r\n* Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug\r\n* Women who are pregnant or breastfeeding\r\n* Women with a positive pregnancy test\r\n* Sexually active fertile men not using effective birth control if their partners are WOCBP
Women of childbearing potential (WOCBP) who: (a) are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for up to 26 weeks after cessation of study drug, or (b) have a positive pregnancy test at baseline, or (c) are pregnant or breastfeeding
Pregnant and/or breastfeeding women are excluded; women of child-bearing potential who are unwilling or unable to use and acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded; male subjects must also agree to use effective contraception for the same period as above
WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
WOCBP who are unwilling or unable to use an acceptable method to minimize the risk of pregnancy for the entire study period and for at least 12 weeks after the last dose of investigational product
Women of childbearing potential (WOCBP), defined above who:\r\n* Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 3 months after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding
Male subjects of reproductive potential who are unwilling or unable to use an acceptable method of contraception with their female partners for their entire study period and for at least 3 months after cessation of study drug
Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug
Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 8 weeks after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding
WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 8 weeks after the last dose of investigational product
WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug
WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of chemotherapy
Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy during the entire study period.
Women of childbearing potential (WOCBP) who:\r\n* Are unwilling or unable to use acceptable methods of contraception to avoid pregnancy for their entire study period and for at least 5 months after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding
Women of childbearing potential (WOCBP) who:\r\n* Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 23 weeks after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding
Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire treatment period and after receipt of brachytherapy; male subjects must also agree to use effective contraception during the treatment period and until 1 year after the completion of brachytherapy
WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
Women of childbearing potential (WOCBP) who:\r\n* Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 8 weeks after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding
Women of childbearing potential (WOCBP), defined above, who:\r\n* Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 26 weeks after cessation of study drug, or\r\n* Have a positive pregnancy test at baseline, or\r\n* Are pregnant or breastfeeding