Definitions |
In the CIOMS publication on definitions of terms and criteria for their use, definitions for aplastic anaemia, agranulocytosis, bone marrow depression, granulocytopenia, leucopenia, neutropenia, and pancytopenia are provided. However, it was not possible to strictly follow those definitions. The definitions in the CIOMS publication include signs and symptoms of cytopenic conditions. The respective signs and symptoms, however, are in such a way unspecific (e.g. headache, pallor, malaise, infections etc.) that it did not seem worthwhile to include them in an SMQ, nor in a broad subgroup. Furthermore, the definitions include distinct ranges of lab values which are not reflected in MedDRA.
|
|
definition |
In the CIOMS publication on definitions of terms and criteria for their use, definitions for aplastic anaemia, agranulocytosis, bone marrow depression, granulocytopenia, leucopenia, neutropenia, and pancytopenia are provided. However, it was not possible to strictly follow those definitions. The definitions in the CIOMS publication include signs and symptoms of cytopenic conditions. The respective signs and symptoms, however, are in such a way unspecific (e.g. headache, pallor, malaise, infections etc.) that it did not seem worthwhile to include them in an SMQ, nor in a broad subgroup. Furthermore, the definitions include distinct ranges of lab values which are not reflected in MedDRA.
|
|
Scope Statement |
In Version 15.1, PT Haemoglobin decreased and PT Haemoglobin abnormal were each added as broad search terms to Haematopoietic erythropenia (SMQ), on the basis of comprehensive testing using a wide variety of drug data. Please be aware that although these terms were successful in identifying cases of interest, they also were frequently associated with reports unrelated to hematopoietic erythropenias.
|
|