Reporting a Pregnancy. Pregnancy and lactation are exclusion criteria. Women of child bearing potential, defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months (ie, who has had menses any time in the preceding 12 consecutive months) must agree to use highly effective contraceptive methods (as defined in Section 5.8.6) while on study drug and for at least 3 months after the last dose of MIRV. In addition, it is recommended that patients undergo monthly pregnancy test for at least 3 months after the last dose of MIRV. The Sponsor must be immediately notified in the event of a pregnancy occurring during the study and through 30 days after a patient’s last dose of study drug. If a patient becomes pregnant the patient will be withdrawn from study drug. Pregnancy is not an AE unto itself and therefore should not be reported as an AE. All pregnancies will be recorded on a Pregnancy Report and submitted according to the contact information on the form and in the completion guidelines. Pregnancies, with the permission of the mother, will be followed to completion or termination using the designated sections of the Pregnancy report form. Any SAE, occurring during the pregnancy to the mother or fetus, would require that a study SAE form also be completed/submitted.
Reporting a Pregnancy. Pregnancy and lactation are exclusion criteria. Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months (ie, who has had menses any time in the preceding 12 consecutive months) must agree to use highly effective contraceptive methods (as defined in Section 5.9.6) while on study drug and for at least 3 months after the last dose of MIRV and for at least 6 months after the last dose of IC Chemo (Pac, PLD, and Topo). In addition, it is recommended that patients undergo monthly pregnancy tests for at least 3 months after the last dose of MIRV. The Sponsor must be immediately notified in the event of a pregnancy occurring during the study and through 30 days after a patient’s last dose of study drug. Pregnancy is not an AE unto itself and therefore should not be reported as an AE. All pregnancies will be recorded on a Pregnancy Report and submitted according to the contact information on the form and in the completion guidelines. Pregnancies, with the permission of the mother, will be followed to completion or termination using the designated sections of the Pregnancy report form. Any SAE, occurring during the pregnancy to the mother or fetus, would require that a study SAE form also be completed/submitted.
