COAGULATION CATEGORY

INR/Prothrombin Time

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