Connect® MDS/AML Disease Registry

This Disease Registry will collect data on patient characteristics, treatment patterns and
clinical outcomes. The objective is to describe how newly diagnosed MDS, ICUS or AML patients
are treated; and to build a knowledge base regarding the effectiveness and safety of
front-line and subsequent treatment regimens in both community and academic settings.
Enrolled patients will receive treatment and evaluations for MDS, ICUS or AML according to
the standard of care and routine clinical practice at each study site. All treatments that
patients receive for MDS, ICUS or AML will be recorded, including initial treatment and any
subsequent therapy. Data on treatment outcomes, including response rates as measured by the
treating physician, evidence of progression, survival, and patient-reported outcomes will be
collected quarterly on the electronic CRF.

Inclusion Criteria:

- Patients must be able to provide written informed consent

- Newly diagnosed (confirmed diagnosis within 60 days prior to date of informed consent
signature), primary or secondary Myelodysplastic Syndromes (MDS), or Acute Myeloid
Leukemia (AML), or Idiopathic Cytopenia of Undetermined Significance (ICUS)

- Disease diagnosis confirmed by Central Eligibility Review

- AML patients must be at least 55 years of age at the time of informed consent
signature

- MDS/ICUS patients must be at least 18 years of age at the time of informed consent
signature

- Patients must be willing and able to complete enrollment and follow-up HRQoL
instruments, for which patients must be proficient in either English or Spanish

Exclusion Criteria:

- Suspected or proven acute promyelocytic leukemia (APL) (FAB M3 or WHO 2008) based on
morphology, immunophenotype, molecular assay or karyotype

- MDS, AML or ICUS cohort assignment by Central Eligibility Review is not confirmed by
site

- For MDS and ICUS patients: receiving active (disease modifying) treatment** prior to
ICF date (Supportive care such as transfusions, antibiotics, iron chelators, EPO,
growth factors (G-CSF/GM-CSF) is allowed)

- For AML patients: receiving active (disease modifying) treatment** that had been
initiated for more than 2 weeks (14 days) prior to ICF date (Supportive care, such as,
transfusions, antibiotics, iron chelators, EPO, growth factors (G-CSF/GM-CSF), tumor
lysis prophylaxis allowed)