--- a +++ b/clusters/9knumclustersv2/clust_1375.txt @@ -0,0 +1,48 @@ +For female subjects of childbearing potential: +Female subjects of childbearing potential must not be pregnant or breastfeeding +Be of non-childbearing potential: +Or, if of childbearing potential, +Female subjects of childbearing potential must: +Male subjects with a female partner of childbearing potential must: +Have a female partner who is NOT of childbearing potential. +Any woman of childbearing potential, unless she: +Be of non-childbearing potential: +Or, if of childbearing potential, +Women of childbearing potential must +Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy. +Women of childbearing potential +Be of non-childbearing potential: +Or, if of childbearing potential: +Female participant without childbearing potential must meet at least one of the following: +Female participant of childbearing potential must meet at least one of the following: +ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Female of childbearing potential (less than months post-menopausal) or male with a partner of childbearing potential either agrees to be abstinent or uses a medically acceptable form of birth control during the study and for a period of year after if on Arm +HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Female of childbearing potential (less than months post-menopausal) or male with a partner of childbearing potential either agrees to be abstinent or uses a medically acceptable form of birth control during the study and for a period of year after if on Arm +Or, if of childbearing potential, +Female Children of Childbearing Potential (FCCBP), Female of Childbearing Potential (FCBP) and male subjects that have reached puberty must agree to undergo physician-approved reproductive education and discuss the side effects of the study therapy on reproduction with parent(s) and/or guardian(s). +Female subjects of childbearing potential must not be pregnant at screening. +Male subjects with a female partner of childbearing potential must: +. Female subjects of childbearing potential may participate, providing they meet the following conditions: +Not a woman of childbearing potential as defined in Appendix VIII OR +Or, if of childbearing potential, +Female participants of childbearing potential must not be pregnant at screening +Or, if of childbearing potential, +A female is eligible to enter and participate in this study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if she is of childbearing potential +Female subjects of childbearing potential must not be pregnant at screening. +Female participants of non-childbearing potential, ? years of age +Or, if of childbearing potential, +Women of childbearing potential +Subjects who desire to get pregnant a female of childbearing potential within the next . years +Women of childbearing potential and men with female sexual partners of childbearing potential must agree to abstain from sexual intercourse or use a double barrier method to determine if a woman is of childbearing potential (http://www.nccn.org/professionals/physician_gls/f_guidelines.asp). +A woman must be either: Not of childbearing potential: postmenopausal (more than [>] years of age with amenorrhea for at least months; If, of childbearing potential must be practicing a highly effective method of birth control +Or, if of childbearing potential, +of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post- menopausal); or, +Or, if of childbearing potential: +Any woman of childbearing potential or male partner of a woman of childbearing potential unwilling to employ acceptable contraception throughout the study and for at least days after the last dose of the study drug +For female patients of childbearing potential, all of the following criteria must be met: +If the participant is of childbearing potential, she should be at least months postpartum +Female subjects of non-childbearing potential may be enrolled in the study. +Female subjects of childbearing potential may be enrolled inthe study, if the subject: +Female subjects of non-childbearing potential may be enrolled in the study. +Female subjects of childbearing potential may be enrolled in the study, if the subject: +Or, if of childbearing potential, +Non-Childbearing Potential: Male subjects and their partners must meet one of the following criteria to be considered of non-childbearing potential: