Clinical trial · Observational
A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia
Onureg® (Oral Azacitidine) Post-Marketing Surveillance in Korean Patients With Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this observational study is to assess the real-world safety of maintenance therapy with oral azacitidine in Korean participants with acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction chemotherapy with or without consolidation therapy, and who are not eligible for hematopoietic stem cell transplantation (HSCT).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral azacitidine | Drug | Azacitidine | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Participants receiving oral azacitidine maintenance therapy
- interventionNames
- Drug: Oral azacitidine
Primary outcomes (1)
- measure
- Number of participants with adverse events (AES)
- timeFrame
- Up to 12 months
- description
- The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to oral azacitidine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Adult participants 19 years of age or older * Participants who receive oral azacitidine according to the approved label * For the first 2 years after marketing authorization, all participants who have received or are receiving oral azacitidine will also be registered * Participants who sign the informed consent form Exclusion Criteria: * Participants who are prescribed oral azacitidine for therapeutic indications not approved in Korea * Participants for whom oral azacitidine is contraindicated per the Korean prescribing information approved by ministry of food and drug safety
References
Publications (0)
Data not yet available