Table 1.

Categorization of the status and outcome of preexisting and treatment-emergent AICs

StatusOutcome
Preexisting AIC status at the start of treatment with targeted drug  
 Resolved Complete blood count normalization, no signs of hemolysis, and no transfusion support or other AIC-directed treatment (including steroids or thrombopoietin mimetics) 
 Controlled Blood counts stable over time but not reaching the normal values, or presence of subclinical hemolysis (hemoglobin within normal limits but high reticulocyte count and/or low serum haptoglobin levels) 
 Active Blood counts decreasing, requiring treatment change or additional medical treatment 
Preexisting AIC outcome during treatment with targeted drug  
 Resolved Complete blood count normalization, no signs of hemolysis, and no transfusion support or other AIC-directed treatment (including steroids or thrombopoietin mimetics) 
 Improved Blood count recovery without complete normalization, or presence of persistent signs of subclinical hemolysis (hemoglobin within normal limits but high reticulocyte count and/or low serum haptoglobin levels) 
 Stable Absence of relevant changes in blood parameters 
 Worsened Worsening of cytopenia or need of additional therapy to control AIC 
Treatment-emergent AIC outcome during treatment with targeted drug  
 Resolved Complete blood count normalization, no signs of hemolysis, and no transfusion support or other AIC-directed treatment (including steroids or thrombopoietin mimetics) 
 Controlled Blood counts stable over time but not reaching normal values, or presence of subclinical hemolysis (hemoglobin within normal limits but high reticulocyte count and/or low serum haptoglobin levels) 
 Active Blood counts decreasing, requiring treatment change or additional medical treatment 
StatusOutcome
Preexisting AIC status at the start of treatment with targeted drug  
 Resolved Complete blood count normalization, no signs of hemolysis, and no transfusion support or other AIC-directed treatment (including steroids or thrombopoietin mimetics) 
 Controlled Blood counts stable over time but not reaching the normal values, or presence of subclinical hemolysis (hemoglobin within normal limits but high reticulocyte count and/or low serum haptoglobin levels) 
 Active Blood counts decreasing, requiring treatment change or additional medical treatment 
Preexisting AIC outcome during treatment with targeted drug  
 Resolved Complete blood count normalization, no signs of hemolysis, and no transfusion support or other AIC-directed treatment (including steroids or thrombopoietin mimetics) 
 Improved Blood count recovery without complete normalization, or presence of persistent signs of subclinical hemolysis (hemoglobin within normal limits but high reticulocyte count and/or low serum haptoglobin levels) 
 Stable Absence of relevant changes in blood parameters 
 Worsened Worsening of cytopenia or need of additional therapy to control AIC 
Treatment-emergent AIC outcome during treatment with targeted drug  
 Resolved Complete blood count normalization, no signs of hemolysis, and no transfusion support or other AIC-directed treatment (including steroids or thrombopoietin mimetics) 
 Controlled Blood counts stable over time but not reaching normal values, or presence of subclinical hemolysis (hemoglobin within normal limits but high reticulocyte count and/or low serum haptoglobin levels) 
 Active Blood counts decreasing, requiring treatment change or additional medical treatment 

AIC definitions are provided in supplemental Table 2.

or Create an Account

Close Modal
Close Modal