A Post-Authorisation Long-Term Retrospective Safety Cohort Study of Arsenic Trioxide in First Line Low- to Intermediate-Risk Acute Promyelocytic Leukaemia (APL) Patients

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ALITRETINOIN

  ARSENIC TRIOXIDE
• Medical condition to be studied:
  Acute promyelocytic 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:
  640

Study design details

• Main study objective:
  To assess the long-term safety of ATO in newly diagnosed low-to- intermediate risk APL patients when used in combination with ATRA in a real-world clinical practice setting.
• Outcomes:
  differentiation syndrome, creatinine, bilirubin, aspartate amino transferase/alanine amino transferase ratio, neurotoxicity, hemorrhage, sepsis, QTc prolongation, cardiac events, congestive heart failure, unexpected serious adverse events including grading and relationship, secondary malignancies, development of therapy-related myelodysplastic syndrome and acute myeloid leukemia, death
• Data analysis plan:
  The incidence rate of endpoints of interest will be assessed and summary statistics for the incidence of these outcomes will be reported. Analysis will be performed by dose and treatment schedule.