A Non-Interventional Post-Authorisation Safety Study to Characterize Toxicity following Gemtuzumab Ozogamicin Treatment and Hematopoietic Stem Cell Transplantation in Adult Patients with Acute Myeloid Leukemia.

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01XC05) gemtuzumab ozogamicin

  gemtuzumab ozogamicin
• Medical condition to be studied:
  Acute myeloid leukaemia

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  This non-interventional study is being conducted to characterize toxicity after hematopoietic stem cell transplantation (HSCT) in adult patients who receive GO post-approval in the US
• Outcomes:
  <IF YES, DESCRIBE, MAX 400 CHARACTERS>Patient-, disease- and HSCT-related characteristics, including details of all prior anti-cancer therapiesTiming of GO treatment prior to HSCT, Incidence of post-HSCT safety events of interest including hepatic VOD/SOS,Transplant-related mortality, non-transplant related mortality, relapse, event-free survival, survival, cause of death
• Data analysis plan:
  Descriptive statistics (ie, frequency, percent, mean, median, standard deviation as appropriate depending on data type) will be used to summarize demographic and baseline clinical characteristics of patients accrued in the study. The cumulative incidence of each safety outcome will be estimated using the cumulative incidence approach (incidence proportion).Cumulative Incidence = (Total new cases during follow-up period / Total persons at risk during follow-up period)