Pregnancy Testing. Pregnancy testing will be performed only for female patients of childbearing potential as indicated in the SoA. A negative serum hCG pregnancy test must be obtained at Screening (≤ 3 days before selinexor administration). A urine hCG test is allowed if serum hCG test is not available. Pregnancy testing may be performed if clinically indicated during the study.
Pregnancy Testing. Medical services during pregnancy and post-partum;
Pregnancy Testing. A RhoGAM injection for all pregnant women who have a negative RH factor according to the established protocol;
Pregnancy Testing. Diagnosis and treatment of sexually transmitted diseases;
Pregnancy Testing. WOCBP should only be included after a negative serum pregnancy test and in accordance with local requirements. When applicable this test should be repeated a maximum of 24- hours before the first dose of trial treatment. Following initiation of treatment additional pregnancy testing will be performed prior to day 1 of each cycle during the treatment period and at 30 days after the last dose of study treatment and as required locally. Pregnancy testing will be performed whenever an expected menstrual cycle is missed or when pregnancy is otherwise suspected.
Pregnancy Testing. All female subjects of childbearing potential must have a negative pregnancy test (urine or serum) at Screening and within 72 hours of the first dose of study treatment. Subsequent pregnancy tests performed every 4 weeks after first dose of study treatment may be either urine or serum. Positive urine tests are to be confirmed by serum testing.
Pregnancy Testing. All WOCBP will have a SPT at the Screening and at Week 16/Early Termination visits and UPT at Injection visit pre-treatment. If any result is positive prior to treatment, the subject will not be allowed to participate. The results of the UPTs for WOCBP will be evaluated at the trial center. WOCBP must use an effective method of birth control during the course of the trial, such as the oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine coil, intrauterine device, tubal ligation, barrier method used WITH an additional form of contraception (e.g., sponge, spermicide or condom), abstinence, no heterosexual intercourse, or has a vasectomized partner. A female is considered to be of childbearing potential UNLESS she is post-menopausal (no menses for 12 consecutive months) or without a uterus and/or both ovaries. Before enrolling WOCBP in this clinical trial, Investigator must review guidelines about study participation for WOCBP. The topics should generally include: • Informed consent document • Pregnancy prevention information • Risks to unborn child(ren) • Any drug interactions with hormonal contraceptives • Contraceptives in current use • Guidelines for the follow-up of a reported pregnancy Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during participation in this clinical trial and the potential risk factors for an unintentional pregnancy. The subject must sign the informed consent document stating that the above-mentioned risk factors and the consequences were discussed with her.
Pregnancy Testing. For women with reproductive potential: serum or urine -HCG (urine test must have a sensitivity of 25-50 mIU/mL). After screening and entry, complete pregnancy testing only when pregnancy is suspected except as noted below.
Pregnancy Testing. Women of childbearing potential should only be included after a confirmed menstrual period and a negative highly sensitive urine pregnancy test at Screening, Baseline (Visit 3, prior to dosing), and at Week 12 or Early Withdrawal. A serum β-human chorionic gonadotropin test must be performed if the urine test is positive. Pregnancy testing will be performed whenever a menstrual cycle is missed or when pregnancy is otherwise suspected.
Pregnancy Testing. A urine pregnancy test will be conducted at Visit 1 and at Visits 6, 10 and 16 (48, 96 and 158 weeks from Visit 2) in all women of childbearing potential. Subjects with a positive pregnancy test should be withdrawn or excluded from entry to the study. If a subject becomes pregnant during the course of the study she must be withdrawn.
