Managing Abnormal Laboratory Test Values Sample Clauses

Managing Abnormal Laboratory Test Values. All safety laboratory tests (haematology and blood biochemistry), for each visit time-point, should be captured in the database from the local laboratory and should not be reported as AEs unless specific treatment is given for the abnormality (e.g. a blood transfusion is given for a low haemoglobin) or a laboratory abnormality leads to further investigation and the diagnosis of a new clinical event (e.g. a high white cell count is found to be due to incidental leukaemia). In this event the clinical diagnosis should be reported on the AE form, not the laboratory abnormality leading to the diagnosis.

Managing Abnormal Laboratory Test Values. All safety laboratory tests (hematology and blood biochemistry provided by the site for each visit time-point, should be captured in the database in the laboratory page and should not be reported as AEs even if qualified as `clinically significant` at site, unless specific treatment is given for the abnormality or if qualifying as grade 4 as per WHO recommendations. Treatment does not refer to platelets or RBC transfusions administered during conditioning and post HSCT or when patient has sign of HLH. If a laboratory abnormality leads to a new clinical diagnosis (e.g., high white cell count is found to be due to incidental leukemia), the new clinical diagnosis should be reported as an AE rather than the laboratory abnormality.