Adverse Events

VERY COMMON AND COMMON ADVERSE EVENTS* THAT OCCURRED DURING TREATMENT1

View the ALFA 0701 study

Please refer to the product SmPC for full details

Table adapted from: MylotargTM Summary of Product Characteristics.
*Only selected safety data were collected in this study of newly-diagnosed AML. †Including fatal outcome.
Veno-occlusive liver disease includes the following reported preferred terms: Veno-occlusive disease and veno-occlusive liver disease. 
§Frequency is based on laboratory values (Grade per NCI CTCAE v4.03). 
ALP, alkaline phosphatase; ALT, alanine aminotransferase; aPTT, activated partial thromboplastin time ; AST, aspartate aminotransferase; NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; PT, prothrombin time; SmPC, Summary of Product Characteristics.

Reference

  1. MYLOTARG™ Summary of Marketing Product Characteristics.

PP-MYL-GBR-0089. December 2019

SERIOUS ADVERSE EVENTS AND ADVERSE EVENTS OF SPECIAL INTEREST1

View the ALFA 0701 study 

Serious adverse events that occurred during treatment

Table adapted from: MylotargTM Summary of Product Characteristics.
*Including fatal outcome. †Infection includes sepsis and bacteraemia (53.4%), fungal infection (15.3%), lower respiratory tract infection (5.3%), bacterial infection (9.2%), gastrointestinal infection (8.4%), skin infection (2.3%) and other infections (28.4%).
Haemorrhage includes central nervous system haemorrhage (3.1%), upper gastrointestinal haemorrhage (33.6%), lower gastrointestinal haemorrhage (17.6%), subcutaneous haemorrhage (60.3%), other haemorrhage (64.9%) and epistaxis (62.6%).
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; VOD, veno-occlusive disease. 

Reference

  1. MYLOTARG™ Summary of Marketing Product Characteristics.

PP-MYL-GBR-0089. December 2019