Common Terminology Criteria for Adverse Events - Instructions and Guidelines
The INR System was established by the World Health Organization and the International Committee on Thrombosis and Hemostasis for monitoring and reporting blood coagulation tests. Under this system, results are standardized using the International Sensitivity Index for the particular test reagent/instrument combination used. The International Normalized Ratio (INR): patient’s PT is compared to the mean PT for a group of normal individuals. The ratio is adjusted for the sensitivity of the laboratory’s thromboplastin determined by the International Sensitivity Index (ISI).
Changes to AEs in this CATEGORY (from CTC v2.0 to CTCAE v3.0)
DIC (disseminated intravascular coagulation) |
Grade 2 added; Grade 4 revised; Grade 3 value revised |
Fibrinogen |
Grades 1-4 revised |
Fibrinogen for leukemia studies or bone marrow infiltrative/myelophthisic process, if specified in the protocol |
Deleted |
Partial thromboplastin time (PTT) |
No change |
Prothrombin time (PT) |
Name revised to v3.0 INR (International Normalized Ratio of prothrombin time) |
Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) |
Grade 1 added |
Thrombotic microangiopathy For BMT studies, if specified in the protocol |
Deleted |
Coagulation – Other (Specify, __) |
No change |