Clinical Safety Laboratory Assessments. All protocol-required laboratory assessments, as defined in Section 10.2 and including urine pregnancy test and drug screen, must be conducted in accordance with the laboratory manual and the Schedule of Assessments (Section 1.3). Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the samples. The clinical significance of test results will be evaluated as follows: • At Screening, the Investigator or physician sub-investigator will assess the clinical significance of any values outside the reference ranges provided by the laboratory, and subjects with abnormalities judged to be clinically significant will be excluded from the study. • The Investigator or physician sub-investigator must review the laboratory report, document this review, and record any clinically relevant changes occurring during the study in the AE section of the eCRF. The laboratory reports must be filed with the source documents. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the Investigator to be more severe than expected for the subject’s condition. • All laboratory tests with values considered clinically significant during participation in the study or within 14 days after the last dose of study drug should be repeated until the values return to normal or baseline or are no longer considered clinically significant by the Investigator or Sponsor’s designated Medical Monitor. - If such values do not return to normal/baseline within a period of time judged reasonable by the Investigator, the etiology should be identified and the Sponsor’s designated Medical Monitor notified. - If laboratory values from nonprotocol-specified laboratory assessments performed at the institution’s local laboratory require a change in subject management or are considered clinically significant by the Investigator (eg, SAE or AE), then the results must be recorded in the eCRF.
Clinical Safety Laboratory Assessments. See Appendix 2 (Section 10.2) for the list of clinical laboratory tests to be performed at the visits designated in the SoA (Section 1.3). Details for collection, processing, and shipping of samples to the central laboratory are provided in a separate Laboratory Manual. • The investigator must review the laboratory report, document this review, and record any clinically relevant changes occurring during the study in the AE section of the eCRF. The signed laboratory reports must be filed with the source documents. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the subject’s condition. • All laboratory tests with values considered abnormal and clinically significant during participation in the study should be repeated per standard practices until the values return to normal or baseline or are no longer considered clinically relevant by the investigator or Sponsor’s Medical Monitor (or designee).
Clinical Safety Laboratory Assessments. Clinical laboratory tests (detailed in Table 6) will be performed by the sites’ local laboratories. In addition, laboratory tests will be collected and analyzed at times specified on the SoA. More frequent assessments may be performed if clinically indicated. Table 6: Clinical Safety Laboratory Tests Hematology Hemoglobin Leukocytes (with differential) Neutrophils Hematocrit Platelet count Monocytes Basophils Lymphocytes Eosinophils Serum Chemistry Sodium Creatinine ALT Potassium Glucose AST Albumin Calcium Alkaline phosphatase Bicarbonate Phosphate Total bilirubin BUN/Urea LDH Total protein Coagulation PT aPTT INR Blood samples will be analyzed at each study center by a certified laboratory. The Investigator or designee will review the laboratory report after receipt of the results and assess the clinical significance of all abnormal values. Results should be reviewed prior to dosing and appropriate action taken for any clinically significant abnormal values. At any time during the study, abnormal laboratory values which are clinically relevant (e.g., require dose modification and/or interruption of study treatment, lead to clinical symptoms or signs or require therapeutic intervention), must be documented in the eCRF. If any abnormal laboratory value or test result constitutes a selinexor related AE, then these must be recorded on the AE eCRF. Values will be documented on the laboratory report until stabilized, or the laboratory value returns to a clinically acceptable range (regardless of relationship to study treatment) or baseline. Any laboratory value that remains abnormal at the End of Study visit that is considered clinically significant will be followed according to accepted medical standards for up to 30 days or until resolution of the abnormality or return to baseline levels. Toxicity will be assessed using the NCI CTCAE, v. 5.0. Karyopharm must be provided with a copy of the laboratory certification and normal ranges for each parameter measured. In addition, if at any time a patient has laboratory parameters obtained from a different outside laboratory, Karyopharm must be provided with a copy of the certification and normal ranges for that laboratory.
