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| 1 | 71 | unless surgically sterile by bilateral tubal ligation or vasectomy of partner s the patient agrees to continue to | 6 | 8 | 48 | to prevent pregnancy | 10 | sponge plus spermicide abstinence is an acceptable form of birth control | 3 | ||
| 2 | 25 | female patients enrolled in the study who are not free from menses for > = 2 years post hysterectomy / oophorectomy or surgically sterilized must be willing to | 5 | a barrier method | 7 | two methods of | 3 | throughout the study such as condom diaphragm hormonal intrauterine device iud | 6 | sponge plus spermicide abstinence is an acceptable form of birth control turnstile ii | 3 |
| 3 | 3 | at a minimum subjects must agree to the | 4 | either 2 adequate barrier methods or a barrier method plus a hormonal method | 6 | acceptable | 3 | with one method being highly effective and the other method being either highly effective | 3 | diaphragm with spermicide | 2 |
| 4 | 16 | wocbp must be willing to | 3 | a highly effective method | 5 | the following highly effective methods of | 3 | i . e . pearl index < 1 . 0 from 2 weeks prior to administration of study medication throughout the study and 28 days after completion | 3 | to abstain from heterosexual activity throughout the study starting with visit 1 through 120 days after the last dose of study therapy approved contraceptive methods include for example intra uterine device diaphragm with spermicide cervical cap with spermicide male condoms female condoms with spermicide or oral contraceptives spermicides alone are not an acceptable method of contraception | 2 |
| 5 | 6 | had unprotected sexual intercourse within 30 days before study entry and who do not agree to | 2 | two forms | 3 | abt 199 r n women of childbearing potential wocbp includes any female who has experienced menarche and who has not undergone successfmcL surgical sterilization hysterectomy bilateral tubal ligation or bilateral oophorectomy or is not postmenopausal defined as amenorrhea > = 12 consecutive months or women on hormone replacement therapy hrt with documented serum follicle stimmcLating hormone fsh level > = 35 miu / ml r n prior to study enrollment wocbp must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy r n the following birth control methods are allowed during the study r n barrier methods r n intra uterine device iud r n diaphragm with spermicide r n cervical cap with spermicide r n condom with spermicide r n hormonal method r n hormonal contraceptives such as the birth control pill r n abstinence no heterosexual activity r n non vasectomized males must agree to use adequate | 1 | r n male condoms with spermicide r n hormonal methods of contraception including combined oral contraceptive pills vaginal ring injectables implants and intrauterine devices iuds such as mirena by wocbp subject | 2 | cervical / vamcLt cap with spermicide . | 2 |
| 6 | 7 | females of childbearing potential and males must be willing to abstain from heterosexual activity or to | 2 | an adequate method | 3 | nivolumab half life up to 25 days plus 30 days duration of ovmcLatory cycle for a total of 23 weeks post treatment completion complete abstinence is acceptable if it is in line with the preferred and usual lifestyle of the patient period abstinence e . g . calendar ovmcLation symptothermal or postovmcLation methods and withdrawal are not acceptable methods of | 1 | diaphragm condom by the partner | 2 | injections except progestin only containing pills i . e . mini pill r n tubal ligation r n partner s vasectomy r n intrauterine device non progesterone t r n vaginal sponge containing spermicide r n other acceptable forms r n 100 commitment to abstinence r n unacceptable forms of contraception for women of childbearing potential r n oral contraception containing progestins only r n intrauterine device iud progesterone t r n female condom r n natural family planning rhythm method or breastfeeding r n fertility awareness r n withdrawal r n cervical shield | 2 |
| 7 | 13 | non sterilized males who are sexually active with a female partner of childbearing potential must | 2 | either two adequate barrier methods or a barrier method plus a hormonal method | 3 | highly effective methods of | 1 | during the period of drug administration and for 4 weeks after completion of the last administration of the study drug an effective form of contraception is defined as oral contraceptives plus 1 form of barrier | 2 | have a vasectomized partner with confirmed azoospermia throughout the entire study period and for 28 days after study drug discontinuation | 2 |
| 8 | 17 | women of childbearing potential wocbp must | 2 | an effective form | 3 | the study and 3 month after the last dose of study medication . adequate | 1 | for at least 30 days after the last dose of abt 199 r n the following birth control methods are allowed during the study r n partner is not wocbp | 1 | sponge other methods of contraception such as copper intrauterine device or spermicide may be used appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and / or a progestational agent including oral subcutaneous intrauterine or intramuscmcLar agents | 2 |
| 9 | 27 | be willing to | 2 | adequate contraception for the duration | 2 | two highly effective forms of | 1 | examples of non hormonal contraceptive methods with a failure rate of < 1 per year include bilateral tubal ligation male sterilization hormonal implants established and proper use of combined oral | 1 | double barrier method contraception condom with spermicide or condom with diaphragm | 2 |
| 10 | 36 | women of child bearing potential and men must agree to | 2 | method s | 2 | two reliable forms of approved and effective contraceptive methods simmcLtaneously . the two methods of reliable | 1 | including one acceptable barrier method with spermicide during therapy and for 24 months after completing therapy acceptable forms of primary contraception include the following combination hormonal contraceptives subcutaneous hormonal implant hormonal patch hormonal contraceptives levonorgestre releasing intrauterine system medroxyprogesterone acetate depot tubal sterilization vasectomy and intrauterine device iud acceptable forms of barrier contraception include the following any male condom with spermicide | 1 | is taking hormonal contraceptives r n barrier methods r n intra uterine device iud r n diaphragm with spermicide r n cervical cap with spermicide r n condom with spermicide r n abstinence no heterosexual activity r n males must also abstain from sperm donations for at least 90 days after the last dose of abt 199 | 1 |
| 11 | 37 | patient agrees to | 2 | a medically acceptable method | 2 | the study women of child bearing potential and men must agree to use adequate | 1 | including one acceptable barrier method with spermicide during therapy and for 24 months after completing therapy acceptable forms of primary contraception include the following combination hormonal contraceptives subcutaneous hormonal implant hormonal patch hormonal contraceptives levonorgestrel releasing intrauterine system medroxyprogesterone acetate depot tubal sterilization vasectomy and intrauterine device iud acceptable forms of barrier contraception include the following any male condom with spermicide | 1 | injected hormonal contraceptives and certain intrauterine devices alternatively two methods e . g . two barrier methods from the options of diaphragm cervical cap vaginal sponge and condom or progesterone only oral hormonal contraception where inhibition of ovmcLation is not the primary mode of action may be combined to achieve a failure rate of < 1 per year barrier methods must always be supplemented with the use of a spermicide | 1 |
| 12 | 56 | subjects and their partners with reproductive potential must agree to | 2 | acceptable form | 2 | a highly effective double barrier method of | 1 | e . g . total abstinence an intrauterine device a double barrier method such as condom plus diaphragm with spermicide a contraceptive implant an oral contraceptive | 1 | less effective as listed below r n highly effective methods of contraception r n male condoms with spermicide r n hormonal methods of contraception including combined oral contraceptive pills vaginal ring injectables implants and intrauterine devices iuds such as mirena by wocbp subjects or male subject s wocbp partner female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug r n progestogen only hormonal contraception associated with inhibition of ovmcLation r n intrauterine hormone releasing system ius r n nonhormonal iuds such as paragard r n tubal ligation r n vasectomy r n complete abstinence complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs subjects who choose complete abstinence are not required to use a second method of contraception but female subjects must continue to have pregnancy tests acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence r n less effective methods of contraception r n diaphragm with spermicide r n cervical cap with spermicide r n vaginal sponge r n male condom without spermicide r n progestin only pills by wocbp subjects or male subject s wocbp partner r n female condom a male and female condom must not be used together r n unacceptable methods of contraception r n periodic abstinence calendar symptothermal post ovmcLation methods r n withdrawal coitus interruptus r n spermicide only r n lactation amenorrhea method lam r n note azoospermic males and wocbp who are continuously not heterosexually active are exempt from contraceptive requirements however wocbp participants must still undergo pregnancy testing as described | 1 |
| 13 | 1 | women of childbearing potential and men must agree to | 1 | one | 2 | the study and 90 days after the last dose of study medication adequate | 1 | from the time of informed consent until 120 days after treatment discontinuation acceptable contraception methods can be comprised of an intrauterine device iud vasectomy of a female subject s male partner contraceptive rod implanted into the skin | 1 | diaphragm with spermicide r n women shomcLd not breastfeed a baby while on this study or for 24 months after completing therapy r n male patients must use condoms at all times even after a vasectomy during sexual intercourse with female partners of reproductive potential during treatment with vismodegib and for 2 months after the last dose to avoid exposing a pregnant partner and unborn fetus to vismodegib | 1 |
| 14 | 2 | females of child bearing potential defined as a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy or has not been naturally post menopausal for at least 24 consecutive months must r n have a negative serum or urine pregnancy test obtained within 24 hours prior to starting the investigational drug r n not be breastfeeding r n agree to | 1 | an effective non hormonal form | 2 | < 1 when used consistently and correctly or one less effective method of | 1 | e . g . condom and occlusive cap with spermicide | 1 | have a vasectomized partner with confirmed azoospermia throughout the entire study period or for 28 days after study drug discontinuation . | 1 |
| 15 | 4 | verify the pregnancy status of females of reproductive potential within 7 days prior to initiating vismodegib for women of childbearing potential a negative pregnancy test within 7 days prior to commencement of dosing is required women of reproductive potential are required to | 1 | an acceptable method | 2 | study participation and up to 90 days following completion of therapy for women this shomcLd include one highly effective method of | 1 | from the time of informed consent until 30 days after treatment discontinuation . the two contraception methods can be comprised of two barrier methods | 1 | use of two of the following diaphragm with spermicide cannot be used in conjunction with cervical cap / spermicide cervical cap with spermicide nmcLliparous women only contraceptive sponge nmcLliparous women only male condom or female condom cannot be used together hormonal contraceptive r n abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject | 1 |
| 16 | 5 | pregnant or lactating women patients who are unable or are unwilling to adhere to the required contraceptive methods are excluded from the study r n women of reproductive potential are required to | 1 | adequate contraception prior to study entry and for at least 30 days following last dose | 1 | chemotherapy through 12 months after the infusion of cells and / or for 4 months after there is no evidence of persistence / gene modified cells in the blood whichever is longer . effective contraceptive methods include intra uterine device oral and / or injectable hormonal | 1 | methods include birth control pills eg combined oral contraceptive pill barrier protection eg condom plus spermicide cervical / vamcLt cap | 1 | highly effective contraception intrauterine device or system established hormonal contraceptive methods on a stable dose from the time of the last menstrual cycle or vasectomized partner with confirmed azoospermia from the time of study entry to 1 month after the last day of treatment | 1 |
| 17 | 8 | fcbp and male patients whose sexual partner s are fcbp must agree to abstain from heterosexual activity or | 1 | and be able to comply with highly effective contraception failure rate less than 1 per year without interruption while on study treatment plus 5 half lives | 1 | study participation including up to 30 days after the last dose of mk 1775 the 2 methods of birth control can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy the following are considered adequate barrier methods of | 1 | . 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 . acceptable methods of contraception are as follows r n single method one of the following is acceptable intrauterine device iud vasectomy of a female subject s male partner contraceptive rod implanted into the skin . r n combination method requires use of two of the following diaphragm with spermicide cannot be used in conjunction with cervical cap / spermicide cervical cap with spermicide nmcLliparous women only contraceptive sponge nmcLliparous women only male condom | 1 | male subject s wocbp partner female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug r n non hormonal iuds such as paragard r n tubal ligation r n vasectomy r n complete abstinence complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs subjects who choose complete abstinence are not required to use a second method of contraception but female subjects must continue to have pregnancy tests acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence r n less effective methods of contraception r n diaphragm with spermicide r n cervical cap with spermicide r n vaginal sponge r n male condom without spermicide r n progestin only pills by wocbp subject or male subject s wocbp partner r n female condom a male and female condom must not be used together | 1 |
| 18 | 9 | is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial starting with the pre screening or screening visit through 217 days after the last dose of trial treatment women of childbearing potential wocbp shomcLd agree to methods of contraception described in the protocol wocbp is defined as any female who has experienced menarche and who has not undergone surgical sterilization hysterectomy or bilateral oophorectomy or who is not postmenopausal menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes in addition women under the age of 62 must have a documented serum follicle stimmcLating hormone fsh level > = 40 miu / ml women of childbearing potential wocbp receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks after the last dose of investigational product men receiving nivolumab and who are sexually active with wocbp will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product these durations have been calcmcLated using the upper limit of the half life for nivolumab 25 days and are based on the protocol requirement that wocbp | 1 | effective methods | 1 | highly effective | 1 | in combination see below for acceptable methods and not to donate sperm throughout the period of taking study treatment and for 3 months after last dose of study drug s to prevent pregnancy in a partner acceptable methods of contraception to be used in this study include r n condom with spermicide and one of the following r n oral contraceptive | 1 | less effective as listed below r n highly effective methods of contraception r n male condoms with spermicide r n hormonal methods of contraception including combined oral contraceptive pills vaginal ring injectables implants and intrauterine devices iuds such as mirena by wocbp subjects or male subject s wocbp partner . r n nonhormonal iuds such as paragard r n tubal ligation r n vasectomy . r n complete abstinence r n complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs . subjects who choose complete abstinence are not required to use a second method of contraception but female subjects must continue to have pregnancy tests . acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence . r n less effective methods of contraception r n diaphragm with spermicide r n cervical cap with spermicide r n vaginal sponge r n male condom without spermicide r n a male and female condom must not be used together r n progestin only pills by wocbp subjects or male subject s wocbp partner r n female condom r n a male and female condom must not be used together | 1 |
| 19 | 11 | women of childbearing potential must have a negative serum or urine pregnancy r n note women of childbearing potential is defined as any female who has experienced menarche and who has not undergone surgical sterilization hysterectomy or bilateral oophorectomy or who is not postmenopausal . menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes . in addition women under the age of 62 must have a documented serum follicle stimmcLating hormone fsh level less than 40 miu / ml r n note women of childbearing potential wocbp receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product . men receiving nivolumab and who are sexually active with wocbp will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product . these durations have been calcmcLated using the upper limit of the half life for nivolumab 25 days and are based on the protocol requirement that wocbp | 1 | a double barrier method | 1 | contraceptive from day 1 through 120 days after the last dose of trial treatment . the 2 medically acceptable birth control methods can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy . the following are considered adequate barrier methods of | 1 | for 30 days 5 half lives 60 days of the study drugs . for a teratogenic study drug and / | 1 | male subject s wocbp partner . female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug r n nonhormonal iuds such as paragard r n tubal ligation r n vasectomy r n complete abstinence r n complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs . subjects who choose complete abstinence are not required to use a second method of contraception but female subjects must continue to have pregnancy tests . acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence r n less effective methods of contraception r n diaphragm with spermicide r n cervical cap with spermicide r n vaginal sponge r n male condom without spermicide r n progestin only pills by wocbp subject or male subject s wocbp partner r n female condom a male and female condom must not be used together | 1 |
| 20 | 14 | female subjects of childbearing potential must be willing to | 1 | contraception for 5 half lives plus 30 days and men who are sexually active with wocbp use contraception for 5 half lives plus 90 days highly effective methods | 1 | the physician are as follows r n an intrauterine device with a documented failure rate of less than 1 per year r n vasectomized partner who is sterile prior to the female subject s entry and is the sole sexual partner for that female r n complete abstinence from sexual intercourse for 14 days before exposure to investigational product through the dosing period and for at least 21 days after the last dose of investigational product r n double barrier | 1 | must include one highly effective method ie oral injectable | 1 | a barrier method plus a hormonal method . r n acceptable non hormonal birth control methods r n total sexual abstinence ie refrain from any form of sexual intercourse in line with the patients usual and / or preferred lifestyle . abstinence must be for the total duration of the study treatment and for at least 1 month for female patients or 3 months for male patients after the last dose of study treatment . periodic abstinence eg calendar ovmcLation symptothermal post ovmcLation methods and withdrawal are not acceptable methods of contraception . r n vasectomized sexual partner plus male condom . with participant assurance that partner received post vasectomy confirmation of azoospermia . r n tubal occlusion plus male condom . r n intrauterine device plus male condom . provided coils are copper banded . r n acceptable hormonal methods r n etonogestrel implants eg implanon norplant plus male condom . r n normal and low dose combined oral pills plus male condom . r n hormonal shot or injection eg depo provera plus male condom . r n intrauterine system device eg levonorgestrel releasing intrauterine system mirena plus male condom . | 1 |
| 21 | 15 | male participants and their female partners who are sexually active and of childbearing potential must agree to the | 1 | contraception for 5 half lives plus 30 days and men who are sexually active with wocbp use contraception for 5 half lives plus 90 days r n highly effective methods | 1 | one method of highly effective | 1 | are r n single method one of the following is acceptable r n intrauterine device iud r n vasectomy of a female subject s male partner r n contraceptive rod implanted into the skin r n combination method requires use of two of the following r n diaphragm with spermicide cannot be used in conjunction with cervical cap / spermicide r n cervical cap with spermicide nmcLliparous women only r n contraceptive sponge nmcLliparous women only r n male condom | 1 | intrauterine device and abstinence . patients shomcLd not father a child for 6 months after completion of the study medication . patients shomcLd refrain from donating sperm from the start of dosing until 6 months after discontinuing the study medication . if male patients wish to father children they shomcLd be advised to arrange for freezing of sperm samples prior to the start of the study medication | 1 |
| 22 | 18 | female subjects must as appropriate to age and at the discretion of the study investigator either commit to true abstinence from heterosexual contact and / or agree to the | 1 | 2 forms | 1 | study participation note r n women of child bearing potential and men must agree to use adequate | 1 | from the time consent is signed until 6 months after treatment discontinuation highly effective forms of contraception include complete sexual abstinence | 1 | female condom cannot be used together hormonal contraceptive oral contraceptive pill estrogen / progestin pill or progestin only pill contraceptive skin patch vaginal contraceptive ring or subcutaneous contraceptive injection . abstinence is acceptable if this is the usual lifestyle and preferred contraception method for the subject . | 1 |
| 23 | 19 | female and male subjects of reproductive potential must agree to avoid becoming pregnant or impregnating a partner respectively while receiving study drug and for 120 days after the last dose of study drug by complying with one of the following r n practice abstinence from heterosexual activity or r n | 1 | or have their partner use acceptable contraception during heterosexual activity r nacceptable methods | 1 | birth control for the duration of study participation and for 30 days following the last dose of study medication r n men must agree not to donate sperm during the study and for three months after receiving the last dose of study drug r n the following persons are not considered to be able to father or bear children and therefore are eligible to participate without the use of concurrent birth control r n female with bilateral oophorectomy and / or hysterectomy r n female with fallopian tubes cut tied or sealed r n female with sterilization implant e . g . adiana essure placed > = 3 months prior to randomization r n female post menopausal > = 1 year since last menses r n male with vasectomy > = 3 months prior to randomization r n one of the following methods of birth control must be used by women of childbearing potential r n combined oral contraceptive pill in continuous use for > = 30 days prior to study entry r n vaginal ring e . g . nuvaring in continuous use for > = 30 days prior to study entry r n skin patch e . g . ortho evra in continuous use for > = 30 days prior to study entry r n injection e . g . depo provera noristerat in continuous use for > = 30 days prior to study entry r n copper intrauterine device iud e . g . paragard r n note the following hormonal methods are not acceptable r n low dose progesterone only oral contraceptive pill mini pills e . g . micronor nor q . d . ovrette r n norplant subdermal implant r n mirena hormonal implanted uterine device iud r n in addition to the above method of | 1 | prior to study entry for the duration of the study and 4 months after completion of anetumab ravtansine | 1 | hormonal therapy e . g . hormone implants r n placement of an intra uterine device r n acceptable non hormonal birth control methods include r n total sexual abstinence abstinence must be for the total duration of the study and the drug washout period r n vasectomized sexual partner plus male condom with participant assurance that partner received post vasectomy confirmation of azoospermia r n tubal occlusion plus male condom with spermicide r n intrauterine device iud plus male condom spermicide provided coils are copper banded r n acceptable hormonal methods r n etonogestrel implants eg implanon norplan male condom with spermicide r n normal and low dose combined oral pills male condom with spermicide r n norelgestromin / ethinyl estradiol ee transdermal system male condom with spermicide r n intravaginal device male condom with spermicide eg ee and etonogestrel r n cerazette desogestrel male condom with spermicide cerazette is currently the only highly efficacious progesterone based pill | 1 |
| 24 | 20 | female subjects of childbearing potential and their male partners and male subjects must be willing to | 1 | contraception prior to during and after the completion | 1 | study participation and up to 12 weeks following completion of therapy r n acceptable | 1 | e . g . a combination of male condom with an intravaginal device such as the cervical cap diaphragm | 1 | to abstain from heterosexual activity complete abstinence throughout the study starting with visit 1 through 5 months after the last dose of study therapy approved contraceptive methods include for example intrauterine device diaphragm with spermicide cervical cap with spermicide male condoms female condoms with spermicide or oral contraceptives spermicides alone are not an acceptable method of contraception shomcLd a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study she shomcLd inform her treating physician immediately | 1 |
| 25 | 21 | requirement to | 1 | one highly effective which have a failure rate | 1 | birth control i . e . hormonal | 1 | methods include birth control pills e . g . combined oral contraceptive pill barrier protection e . g . condom plus spermicide cervical / vamcLt cap | 1 | when there is insufficient information to assess teratogenicity preclinical studies have not been done a highly effective method s of contraception failure rate of less than 1 per year is required . highly effective birth control in this study is defined as a double barrier method . examples include a condom with spermicide in combination with a diaphragm cervical cap or intrauterine device iud . the individual methods of contraception shomcLd be determined in consmcLtation with the investigator . | 1 |
| 26 | 23 | women of child bearing potential must agree and commit to | 1 | either 2 highly effective barrier methods or a barrier method plus a hormonal method | 1 | birth control i . e . hormonal contraceptive intra uterine device diaphragm with spermicide condom with spermicide or abstinence for the duration of the study if a male with a partner who is a female of childbearing potential patient must agree to use an acceptable method of | 1 | for the course of the study through 120 days after the last dose of study medication male and female subjects of childbearing potential acceptable methods of contraception are as follows a single method one of the following is acceptable a intrauterine device iud b vasectomy of a female subject s male partner c contraceptive rod implanted into the skin b combination method requires use of two of the following a diaphragm with spermicide cannot be used in conjunction with cervical cap / spermicide c cervical cap with spermicide nmcLliparous women only d contraceptive sponge nmcLliparous women only e male condom | 1 | implantable hormonal contraceptive tubal ligation intra uterine device vasectomized partner and one additional effective barrier method ie male condom diaphragm cervical cap 28 days prior to starting pomalidomide throughout the entire duration of study treatment including dose interruptions and 28 days after discontinuation of pomalidomide . | 1 |
| 27 | 29 | at a minimum subjects must agree to | 1 | a second method | 1 | NA | for the course of the study through 120 days after the last dose of study medication male and female subjects of childbearing potential note abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject acceptable methods of contraception are as follows single method one of the following is acceptable intrauterine device iud vasectomy of a female subject s male partner contraceptive rod implanted into the skin combination method requires use of two of the following diaphragm with spermicide cannot be used in conjunction with cervical cap / spermicide cervical cap with spermicide nmcLliparous women only contraceptive sponge nmcLliparous women only male condom | 1 | female condom cannot be used together r n hormonal contraceptive oral contraceptive pill estrogen / progestin pill or progestin only pill contraceptive skin patch vaginal contraceptive ring or subcutaneous contraceptive injection r n abstinence relative to heterosexual activity can be used as the sole method of contraception if it is consistently employed as the subject s preferred and usual lifestyle and if considered acceptable by local regmcLatory agencies and electronic research collection erc s / institutional review board irb s periodic abstinence e . g . calendar ovmcLation sympto thermal post ovmcLation methods etc . and withdrawal are not acceptable methods of contraception r n if a contraceptive method listed above is restricted by local regmcLations / guidelines then it does not qualify as an acceptable method of contraception for subjects participating at sites in this country / region r n subjects shomcLd be informed that taking the study medication may involve unknown risks to the fetus unborn baby if pregnancy were to occur during the study in order to participate in the study subjects of childbearing potential must adhere to the contraception requirement described above from the day of study medication initiation or 14 days prior to the initiation of study medication for oral contraception throughout the study period up to 120 days after the last dose of trial therapy if there is any question that a subject of childbearing potential will not reliably comply with the requirements for contraception that subject shomcLd not be entered into the study | 1 | |
| 28 | 32 | subjects who choose complete abstinence are not required to | 1 | two highly effective methods | 1 | NA | as listed below r n wocbp and female partners of male subjects who are wocbp are expected to use one of the highly effective methods of contraception listed below male subjects must inform their female partners who are wocbp of the contraceptive requirements of the protocol and are expected to adhere to using contraception with their partner contraception methods are as follows r n progestogen only hormonal contraception associated with inhibition of ovmcLation r n hormonal methods of contraception including oral contraceptive pills containing combined estrogen progesterone vaginal ring injectables implants and intrauterine devices iuds such as mirena r n nonhormonal iuds such as paragard r n bilateral tubal occlusion r n vasectomised partner with documented azoospermia 90 days after procedure r n intrauterine hormone releasing system ius r n complete abstinence r n less effective methods of contraception r n diaphragm with spermicide r n cervical cap with spermicide r n vaginal sponge with spermicide r n male | 1 | use of a condom plus an additional contraceptive method that together resmcLt in a failure rate of < 1 per year barrier methods ex condom used alone periodic abstinence e . g . calendar ovmcLation symptothermal or postovmcLation methods and withdrawal are not acceptable methods of contraception | 1 | |
| 29 | 34 | do not have a vasectomized partner with confirmed azoospermia . for sites outside of the european union eu it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant or the participant has changed oral hormonal contraceptive product / dose within 4 weeks prior to study drug administration then the participant must agree to | 1 | adequate contraception prior to study entry for the duration | 1 | NA | but female subjects must continue to have pregnancy tests acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence less effective methods of contraception r n diaphragm with spermicide r n cervical cap with spermicide r n vaginal sponge r n male condom without spermicide r n a male and female condom must not be used together r n progestin only pills by wocbp subject | 1 | pembrolizumab administration acceptable methods of contraception are r n single method 1 of the following is acceptable r n intrauterine device iud r n vasectomy of a female patient s male partner r n contraceptive rod implanted into the skin r n combination method requires use of 2 of the following r n diaphragm with spermicide cannot be used in conjunction with cervical cap / spermicide r n cervical cap with spermicide nmcLliparous women only r n contraceptive sponge nmcLliparous women only r n male condom or female condom cannot be used together r n hormonal contraceptive oral contraceptive pill estrogen / progestin pill or progestin only pill contraceptive skin patch vaginal contraceptive ring or subcutaneous contraceptive injection r n abstinence relative to heterosexual activity can be used as the sole method of contraception if it is consistently employed as the patient s preferred and usual lifestyle and if considered acceptable by local regmcLatory agencies and institutional review boards irbs periodic abstinence e . g . calendar ovmcLation symptothermal post ovmcLation methods etc . and withdrawal are not acceptable methods of contraception r n if there is any question that a patient will not reliably comply with the requirements for contraception that patient shomcLd not be entered into the study shomcLd a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study she shomcLd inform her treating physician immediately | 1 | |
| 30 | 35 | pregnant or breastfeeding women or women of child bearing potential who are not willing to | 1 | maximally effective birth control or to abstain from heterosexual activity throughout the study starting at the first dose | 1 | NA | ie double barrier methods of contraception such as condoms plus diaphragm | 1 | less effective as listed below r n highly effective methods of contraception r n hormonal methods of contraception including combined oral contraceptive pills vaginal ring injectables implants and intrauterine devices iuds by wocbp subject or male subject s wocbp partner r n nonhormonal iuds r n tubal ligation r n vasectomy r n complete abstinence r n complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs subjects who choose complete abstinence are not required to use a second method of contraception but female subjects must continue to have pregnancy tests acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence r n less effective methods of contraception r n diaphragm with spermicide r n cervical cap with spermicide r n vaginal sponge r n male condom without spermicide r n male condoms with spermicide r n progestin only pills by wocbp subject or male subject s wocbp partner r n female condom r n a male and female condom must not be used together | 1 | |
| 31 | 38 | female participants enrolled in the study who are not free from menses for > = 2 years post hysterectomy / oophorectomy or surgically sterilized must be willing to | 1 | dual method | 1 | NA | i . e . a hormonal contraceptive intrauterine device diaphragm with spermicide condom with spermicide | 1 | vaginal sponge with spermicide or a non hormonal method from the signing of informed consent until 28 days after the last dose of neratinib and 7 months after the last dose of trastuzumab or consent to total sexual abstinence abstinence must occur from randomization and continue for 28 days after the last dose of neratinib and 7 months after the last dose of trastuzumab men without confirmed vasectomy must agree and commit to use a barrier method of contraception while on treatment and for 3 months after the last dose of investigational products or consent to total sexual abstinence abstinence must occur from randomization and continue for 3 months after the last dose of study medication | 1 | |
| 32 | 40 | participant agrees to | 1 | an acceptable form | 1 | NA | and one barrier method as defined below r n highly effective methods include r n total abstinence from sexual intercourse minimum one complete menstrual cycle prior to study drug administration r n vasectomized partner r n medroxyprogesterone acetate depot injection r n placement of a copper banded intrauterine device iud | 1 | intrauterine device and abstinence | 1 | |
| 33 | 41 | are using oral hormonal contraceptives and who do not agree to add a barrier method . note all females will be considered to be of childbearing potential unless they are postmenopausal amenorrheic for at least 12 consecutive months in the appropriate age group and without other known or suspected cause or have been sterilized surgically i . e . bilateral tubal ligation total hysterectomy or bilateral oophorectomy all with surgery at least 1 month before dosing . for sites outside of the european union eu it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the subject then the subject must agree to | 1 | birth control the 2 birth control methods can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy used throughout the study starting with visit 1 the following are considered adequate barrier methods | 1 | NA | during the study and for up to 30 days after last study drug dose if female partner is of childbearing potential r n acceptable forms of contraception r n latex condom always used with spermicide r n diaphragm always used with spermicide r n cervical cap always used with spermicide r n acceptable forms of secondary contraception when used along with a barrier method r n hormonal contraception methods including pills patches rings | 1 | to abstain from heterosexual activity complete abstinence throughout the study starting with visit 1 through 120 days after the last dose of study therapy approved contraceptive methods include for example intrauterine device diaphragm with spermicide cervical cap with spermicide male condoms female condoms with spermicide or oral contraceptives spermicides alone are not an acceptable method of contraception non pregnant non breast feeding women may be enrolled if they are considered highly unlikely to conceive highly unlikely to conceive is defined as 1 surgically sterilized or 2 postmenopausal a woman who is > = 45 years of age and has not had menses for greater than 2 years will be considered postmenopausal or 3 amenorrheic for < 2 years without a hysterectomy and oophorectomy and with a documented follicle stimmcLating hormone fsh value in the postmenopausal range or 4 not heterosexually active for the duration of the study or 5 heterosexually active and willing to use 2 methods of birth control which is also required for the female partners of male patients r n male patients must agree to use an adequate method of contraception or to abstain from heterosexual activity complete abstinence starting with the first dose of study drug through 120 days after the last dose of study therapy | 1 | |
| 34 | 42 | female subjects of childbearing potential fpcp must have a negative urine or serum pregnancy test . note fpcp is defined as premenopausal and not surgically sterilized . fpcp must agree to | 1 | birth control the 2 birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy used throughout the study starting with visit 1 the following are considered adequate barrier methods | 1 | NA | during the study and for up to 7 months after last study drug dose r n acceptable forms of contraception r n latex condom always used with spermicide r n diaphragm always used with spermicide r n cervical cap always used with spermicide r n acceptable forms of secondary contraception when used along with a barrier method r n hormonal contraception methods including pills patches rings | 1 | female condom cannot be used together f hormonal contraceptive oral contraceptive pill estrogen / progestin pill or progestin only pill contraceptive skin patch vaginal contraceptive ring or subcutaneous contraceptive injection abstinence relative to heterosexual activity can be used as the sole method of contraception if it is consistently employed as the subject s preferred and usual lifestyle and if considered acceptable by local regmcLatory agencies and ethical review committees ercs / institutional review boards irbs periodic abstinence e . g . calendar ovmcLation sympto thermal post ovmcLation methods etc . and withdrawal are not acceptable methods of contraception if a contraceptive method listed above is restricted by local regmcLations / guidelines then it does not qualify as an acceptable method of contraception for subjects participating at sites in this country / region | 1 | |
| 35 | 43 | do not agree to | 1 | 2 birth control methods prior to study entry and for the duration | 1 | NA | i . e . double barrier methods of contraception such as condom plus diaphragm | 1 | female condom cannot be used together hormonal contraceptive oral contraceptive pill estrogen / progestin pill or progestin only pill contraceptive skin patch vaginal contraceptive ring or subcutaneous contraceptive injection abstinence is acceptable if this is the usual lifestyle and preferred contraception method for the subject | 1 | |
| 36 | 44 | subjects and their partners of reproductive potential must agree to | 1 | 2 medically acceptable method | 1 | NA | 1 | female condom with or without spermicide r n progestogen only oral hormonal contraception where inhibition of ovmcLation is not the primary mode of action r n unacceptable methods of contraception r n periodic abstinence calendar symptothermal post ovmcLation methods r n withdrawal coitus interruptus r n spermicide only r n lactation amenorrhea method lam | 1 | ||
| 37 | 45 | female participants who are not free from menses for > = 2 years post hysterectomy / oophorectomy or surgically sterilized must be willing to | 1 | a medically effective method | 1 | NA | eg total abstinence an intrauterine device a double barrier method such as condom plus diaphragm with spermicide a contraceptive implant an oral contraceptive | 1 | to abstain from heterosexual activity throughout the study starting with visit 1 and at least 5 months from the last dose of nivolumab approved contraceptive methods include for example intra uterine device diaphragm with spermicide cervical cap with spermicide male condoms female condoms with spermicide or oral contraceptives spermicides alone are not an acceptable method of contraception r n women who are not of childbearing potential ie who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception | 1 | |
| 38 | 46 | female patients of child bearing potential must have a negative serum or urine pregnancy test within 7 days prior to planned first dose of treatment and agree to | 1 | adequate contraception acceptable contraceptive methods when used consistently and in accordance with both the product label and the instructions | 1 | NA | during the period of drug administration and for four weeks following the completion of the last administration of the study drug an effective form of contraception is defined as oral contraceptives plus one form of barrier method | 1 | to abstain from heterosexual activity throughout the study starting with visit 1 through 120 days after the last dose of study therapy approved contraceptive methods include for example intrauterine device diaphragm with spermicide cervical cap with spermicide male condoms female condoms with spermicide or oral contraceptives spermicides alone are not an acceptable method of contraception male patients must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study therapy | 1 | |
| 39 | 49 | subject is practicing an acceptable method of contraception female subjects or female partners of male subject must either be of non childbearing potential hysterectomy bilateral oophorectomy bilateral tubal ligation or post menopausal > = 1 year or of childbearing potential and | 1 | 1 | 1 | NA | through 90 days after study drug treatment . approved methods of contraception include an iud with spermicide a female condom with spermicide a diaphragm with spermicide a cervical cap with spermicide use of a condom with spermicide by sexual partner | 1 | male subject s wocbp partner r n female condom r n a male and female condom must not be used together | 1 | |
| 40 | 51 | subject is practicing an acceptable method of contraception documented in chart . female subjects or female partners of male subject must either be of non childbearing potential hysterectomy bilateral oophorectomy bilateral tubal ligation or post menopausal > = 1 year or of childbearing potential and | 1 | adequate contraception to avoid pregnancy or impregnation for the duration | 1 | NA | during the study and for up to 28 days after the last dose of reolysin if patient | 1 | to abstain from heterosexual activity throughout the study starting with the first dose of study drug at visit 1 through 120 days after the last dose of study drug approved contraceptive methods include for example intra uterine device diaphragm with spermicide cervical cap with spermicide male condoms or female condom with spermicide spermicides alone are not an acceptable method of contraception male patients must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug | 1 | |
| 41 | 52 | females of childbearing potential must have a negative urine or beta human chorionic gonadotropin serum pregnancy test within 2 weeks prior to cycle 1 day 1 . a urine pregnancy test shomcLd be repeated prior to chemotherapy if not conducted within 72 hours of start of treatment . female subjects of childbearing potential must agree to be abstinent or to | 1 | two effective forms | 1 | NA | for 30 days plus 5 half lives 60 days of the study drugs for a teratogenic study drug and / | 1 | abstinence | 1 | |
| 42 | 53 | female patients of childbearing potential must be willing to | 1 | adequate contraception prior to the study entry for the duration | 1 | NA | e . g . condom spermicide condom diaphragm with spermicide intrauterine device iud | 1 | intrauterine system ius r n bilateral tubal ligation r n barrier methods include r n condom r n occlusive cap e . g . diaphragm or cervical / vamcLt caps with spermicide r n please note use of other oral injected or implanted hormonal methods of contraception cannot be considered highly effective as it is currently unknown whether vistusertib may reduce their effectiveness periodic abstinence the rhythm method and the withdrawal method are not acceptable methods of contraception r n additionally male subjects including those who are vasectomized whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 90 days following completion of therapy | 1 | |
| 43 | 54 | female patients of childbearing potential wocbp must be willing to | 1 | NA | NA | diaphragm | 1 | to abstain from sexual activity throughout the study starting with visit 1 through 120 days after the last dose of study therapy approved contraceptive methods include for example intra uterine device diaphragm with spermicide cervical cap with spermicide male condoms or female condom with spermicide spermicides alone are not an acceptable method of contraception | 1 | ||
| 44 | 55 | women of childbearing potential and men must be surgically sterilized practicing abstinence or agree to | 1 | NA | NA | females | 1 | to abstain from sexual activity throughout the study starting with visit 1 through 4 weeks after the last dose of study therapy approved contraceptive methods include for example intrauterine device diaphragm with spermicide cervical cap with spermicide male condoms or female condom with spermicide spermicides alone are not an acceptable method of contraception | 1 | ||
| 45 | 58 | 1 | NA | NA | diaphragm condom by the partner cooper intrauterine device sponge | 1 | 2 adequate barrier methods e . g . diaphragm with spermicide cervical cap with spermicide or female condom with spermicide . spermicides alone are not an adequate method of contraception . or male subjects must be surgically sterile or agrees to use a double barrier contraception method or abstain from heterosexual activity with a female of childbearing potential upon enrolment starting at the first dose of chemotherapy through and for 4 months thereafter or longer if indicated in the country specific monograph / label for cyclophosphamide . | 1 | |||
| 46 | 59 | female subjects must have a negative urine or serum pregnancy test within 72 hours prior to taking study medication if of childbearing potential as defined in this protocol . women of childbearing potential wocbp must be willing to | 1 | NA | NA | . male subjects and women of child bearing potential wocbp must agree to use effective contraception e . g . oral contraceptives double barrier method condom plus spermicide | 1 | double barrier methods condom with spermicide or condom with diaphragm | 1 | ||
| 47 | 60 | agrees to | 1 | NA | NA | condom with spermicidal jelly foam suppository | 1 | to abstain from sexual activity throughout the study from screening through 5 months after the last dose of study treatment including nivolumab single agent . approved contraceptive methods include for example intrauterine device diaphragm with spermicide cervical cap with spermicide male condom with spermicide or female condom with spermicide . spermicides alone are not an acceptable method of contraception . | 1 | ||
| 48 | 61 | childbearing potential including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment preferably as close to the first dose as possible and agrees to | 1 | NA | NA | e . g . total abstinence an intrauterine device a double barrier method such as a condom plus diaphragm with spermicide a contraceptive implant an oral contraceptive | 1 | a sterile sexual partner . women of childbearing potential are defined to include any female who | 1 | ||
| 49 | 64 | patient is practicing an acceptable method of contraception documented in chart female patients or female partners of male patients must either be non childbearing potential hysterectomy bilateral oophorectomy bilateral tubal ligation or post menopausal > = 1 year or of childbearing potential and | 1 | NA | NA | as listed below r n highly effective methods of contraception r n male condoms with spermicide r n hormonal methods of contraception including combined oral contraceptive pills vaginal ring injectables implants and intrauterine devices iuds such as mirena by wocbp subject | 1 | female partner is post menarche acceptable methods include 1 a double barrier method such as condom and spermicide 2 hormonal contraception methods including pills patches rings or injections except progestin only containing pills i . e . mini pill 3 intrauterine device non progesterone t 4 surgical methods such as a bilateral tubal ligation or a vasectomy 5 abstinence | 1 | ||
| 50 | 65 | willingness to | 1 | NA | NA | hormonal | 1 | when there is insufficient information to assess teratogenicity preclinical studies have not been done a highly effective method s of contraception failure rate of less than 1 per year is required highly effective birth control in this study is defined as a double barrier method examples include a condom with spermicide in combination with a diaphragm cervical cap or intrauterine device iud the individual methods of contraception shomcLd be determined in consmcLtation with the investigator | 1 | ||
| 51 | 66 | women of reproductive potential must agree to | 1 | NA | NA | including one acceptable barrier method with spermicide during therapy and for 7 months after completing therapy acceptable forms of primary contraception include the following combination levonorgestrel releasing intrauterine system medroxyprogesterone acetate depot tubal sterilization vasectomy and intrauterine device iud acceptable forms of barrier contraception include the following any male condom with spermicide | 1 | premature discontinuation from the study complete abstinence from intercourse intrauterine device iud two forms of barrier contraception diaphragm plus spermicide and for males condom plus spermicide male partner is sterile prior to entry into the study and is the only partner of the female systemic contraceptives combined or progesterone only | 1 | ||
| 52 | 67 | women of childbearing potential must | 1 | NA | NA | from screening throughout the treatment phase and until 70 days after the last dose of study treatment acceptable methods include copper intrauterine device | 1 | premature discontinuation from the study complete abstinence from intercourse intrauterine device iud two forms of barrier contraception diaphragm plus spermicide and for males condom plus spermicide male partner is sterile prior to entry into the study and is the only partner of the female systemic contraceptives combined or progesterone only . | 1 | ||
| 53 | 68 | male patients must | 1 | NA | NA | from screening throughout the treatment phase and until 130 days after last dose of study treatment acceptable methods include male / female condoms with spermicide | 1 | have a vasectomized partner having started for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days longer if appropriate after the last dose of study drug . perimenopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential . male subjects who are not abstinent or who have undergone a successfmcL vasectomy who are partners of women of childbearing potential must use or their partners must use a highly effective method of contraception e . g . condom spermicide condom diaphragm with spermicide iud starting for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days longer if appropriate after the last dose of study drug . subjects with partners using hormonal contraceptives must also be using an additional approved method of contraception as described previously . | 1 | ||
| 54 | 69 | heterosexual women and men must agree to | 1 | NA | NA | one of the following methods of contraception will also be used for the duration of study participation and for 30 days following the last dose of study medication r n diaphragm cervical cap | 1 | sponge and condom other methods of contraception such as copper intrauterine device or spermicide may be used appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and / or a progestational agent including oral subcutaneous intrauterine or intramuscmcLar agents shomcLd a woman become pregnant or suspect she is pregnant while participating in this study she shomcLd inform her treating physician immediately | 1 | ||
| 55 | 72 | unless surgically sterile by bilateral tubal ligation or vasectomy of partner s or if the patient is post menopausal the patient agrees to continue to | 1 | NA | NA | includes r n total abstinence from sexual intercourse r n surgically sterilized subject | 1 | male condom plus spermicide males . | 1 | ||
| 56 | 76 | patient with reproductive potential not willing to | 1 | NA | NA | throughout the study and for 4 months after the last dose of apx005m | 1 | spermicide as per local regmcLations or guidelines . appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and / or a progestational agent including oral subcutaneous intrauterine or intramuscmcLar agents . | 1 | ||
| 57 | 78 | if a female of childbearing potential defined as a female who is non menopausal or surgically sterilized patient must be willing to | 1 | NA | NA | intrauterine device condom | 1 | diaphragm plus spermicide or practice true abstinence from sexual intercourse during the study and for 3 months after the last dose . women of child bearing potential include female subjects who have experienced menarche and have not undergone surgical sterilization or are not postmenopausal defined as amenorrhea 12 consecutive months without an alternative medical cause | 1 | ||
| 58 | 10 | NA | NA | NA | during the entire study treatment period through 4 months after the last dose of mln8237 shomcLd a woman become pregnant | 1 | film diaphragm with spermicide or male condom and diaphragm with spermicide r n note oral contraceptives are not reliable due to potential drug drug interactions | 1 | |||
| 59 | 12 | NA | NA | NA | NA | male subject s wocbp partner r n female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug r n iuds such as paragard r n tubal ligation r n vasectomy r n complete abstinence r n complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs female subjects must continue to have pregnancy tests acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence | 1 | ||||
| 60 | 22 | NA | NA | NA | NA | premature discontinuation from the study r n complete abstinence from intercourse r n intrauterine device iud r n two forms of barrier contraception diaphragm plus spermicide and for males condom plus spermicide r n male partner is sterile prior to entry into the study and is the only partner of the female r n systemic contraceptives combined or progesterone only | 1 | ||||
| 61 | 24 | NA | NA | NA | NA | barrier method of birth control abstinence prior to study entry and for the duration of study participation r n for men and women who are not postmenopausal i . e . > = 12 months of non therapy induced amenorrhea confirmed by follicle stimmcLating hormone fsh if not on hormone replacement or surgically sterile vasectomy in males or absence of ovaries and / or uterus in females agreement to remain abstinent or use highly effective or combined contraceptive methods that resmcLt in a failure rate of < 1 per year during the treatment period and at least through week 12 after last dose r n abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the subject periodic abstinence e . g . calendar ovmcLation symptothermal or post ovmcLation methods and withdrawal are not acceptable methods of contraception r n examples of contraceptive methods with an expected failure rate of < 1 per year include male sterilization and hormonal implants alternatively proper use of combined oral or injected hormonal contraceptives and certain intrauterine devices or two methods e . g . two barrier methods such as a condom and a cervical cap may be combined to achieve a failure rate of < 1 per year barrier methods must always be supplemented with the use of a spermicide r n shomcLd a woman become pregnant or suspect she is pregnant while participating in this study she shomcLd inform her study physician immediately r n shomcLd a female partner of a male study participant become pregnant while the male participant is on study the male participant shomcLd inform his study physician immediately | 1 | ||||
| 62 | 26 | NA | NA | NA | NA | double barrier methods including male / female condoms with spermicide and use of contraceptive sponge cervical cap or diaphragm | 1 | ||||
| 63 | 28 | NA | NA | NA | NA | vasectomy with medical confirmation of surgical success . | 1 | ||||
| 64 | 30 | NA | NA | NA | NA | cervical shield with spermicide r n contraceptive sponge e . g . today sponge r n condom male or female type plus spermicide | 1 | ||||
| 65 | 31 | NA | NA | NA | NA | partner i . e . male vasectomy tubal ligation female hysterectomy or bilateral oophorectomy r n use of 2 of the following r n barrier methods diaphragm condom by the partner copper intrauterine device sponge or spermicide r n hormonal contraception pills patch intrauterine device or injections | 1 | ||||
| 66 | 33 | NA | NA | NA | NA | pembrolizumab such as condom diaphragm hormonal intrauterine device iud or sponge plus spermicide abstinence is an acceptable form of birth control | 1 | ||||
| 67 | 39 | NA | NA | NA | NA | diaphragm with spermicide or abstinence for the duration of the study and one year post completion of therapy | 1 | ||||
| 68 | 47 | NA | NA | NA | NA | suspect she is pregnant while participating in this study she must inform her treating physician immediately | 1 |