Pregnancy Test. If you are a woman of child-bearing potential, a urine or blood pregnancy test may be performed. You will be asked to walk back and forth between a start and end point as many times as possible within 6 minutes. You may stop and rest if needed. Right before and right after the test you will be asked questions about how breathless you feel you are.
Pregnancy Test. BBMR Designated Medical Practitioners will notify the contractor of all female donors who have child bearing potential. Child bearing potential will be assessed at the time of final donor medical assessment.
4.1 A pregnancy test must be performed on all notified donors. Refer to G-CSF Home Administration Letter (LET45). The pregnancy test must be confirmed as Negative before the administration of the first injection of G-CSF.
4.2 The attending nurse must record the test result on the Symptom Monitoring of PBSC Donor during the administration of G-CSF Form (FRM674).
4.3 The contractor will supply a CE marked pregnancy test kit to detect the hormone HCG in the urine.
4.4 The attending nurse should counsel the donor in the event of a Negative test, to ensure that adequate contraception is maintained.
4.5 In the event of a Positive test the attending nurse must immediately contact the BBMR Designated Medical Practitioner and the BBMR Medical Director for advice on further action.
4.6 The attending nurse will counsel the donor in the event of a Positive test.
Pregnancy Test. WOCBP (see Section 9.8) will complete a pregnancy test as indicated in Table 3, or at any time if pregnancy is suspected. Negative test results are required on Day 1 before study drug administration. Any patient who becomes pregnant during the study must discontinue taking study drug immediately. See Section 9.8.3 for a description of procedures to be followed in case of pregnancy.
Pregnancy Test. A serum or urine pregnancy test will be performed at Screening for all females of childbearing potential. A pregnancy test also should be performed before the first dose of tazemetostat if the Screening pregnancy test was >72 hrs prior. (Urine or serum test is acceptable however, positive urine tests must be confirmed with serum testing.)
Pregnancy Test. Urine will be collected from females who are of childbearing potential for a pregnancy test and tested in clinic according to site standard procedures.
Pregnancy Test. Women of childbearing potential will be tested for pregnancy by serum pregnancy test at the Screening visit and by urine pregnancy test on Day 1 (predose), and at the follow-up visit. A urine pregnancy test will also be performed as part of the early termination assessments for subjects who discontinue the study early. If a subject becomes pregnant during the study, the process for reporting the pregnancy and guidance for collection of information related to the pregnancy is outlined in the Safety Management Plan.
Pregnancy Test. A serum or urine pregnancy test will be obtained from female subjects who are of childbearing potential as noted in the Schedule of Events.
Pregnancy Test. If you are a woman who may be able to get pregnant, a pregnancy test will be done. The results of this test must show that you are not pregnant in order for you to take part in this study. This test must be done on a blood sample at screening, but may be done on a blood or urine sample when repeated later in the study • ECG: You will have an electrocardiogram done; this is an electrical tracing of your heartbeat. • Echo or MUGA: Either you will have an Echo or a MUGA scan to check the activity and function of your heart, but only if you have a history of heart problems. • Pulmonary function tests: You will have a group of tests that measure how well your lungs work. This includes how well you are able to breathe, and how well your lungs are able to bring oxygen to the rest of your body. • Chest X-ray: A chest x-ray will be done to check the condition of your lungs. • CT scan or MRI: You will have either a CT scan or an MRI to check the status of your disease (unless you have had one of these scans within 28 days of the screening visit and the results are made available to the study doctor). • Stored (archival) tumor sample or tumor biopsy: A request will be made to obtain a sample of your tumor tissue from a previous biopsy or surgery to determine whether your tumor is positive for the target of this study medication and to do biomarker studies. o Providing a sample of tumor tissue is required, and if not available, you will need to undergo a biopsy to collect tumor tissue for testing. The test performed must show that your tumor is positive for the target of this study medication for you to be eligible for the study, and there must be enough tumor tissue to perform the other required biomarker studies. Once it is confirmed that you are eligible for the study, and it is safe for you to take part, the following will be done: • A blood sample will be taken to do tests on tumor cells that may be circulating in your blood If your Screening tests show that you can take part in this study, you will receive the study medication into your vein (IV) on Day 1 of each 21-day (3-week) cycle. Your study doctor will also provide you with premedications to take by mouth. You will take these medications at home about 12 hours and about 6 hours before each of your scheduled infusions of study drug.
Pregnancy Test. A urine sample will be collected for a human chorionic gonadotropin pregnancy test as per the schedule in Table 4 and Table 5, for all female subjects of childbearing potential. If this is found to be positive, it will be followed-up with a serum pregnancy test (β-human chorionic gonadotropin). Any subject becoming pregnant during the study will be withdrawn. All pregnancies that occur during the study are to be reported as described in Section 8.1.5.
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