None listed
Conditions
Interventions
None listed
Sponsors
Sanofi-Aventis Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pediatric and adult patients aged 12 years and older 2. Patients who have received or are receiving Rezurock according to approved indications in South Korea 3. Patients or their legal representatives who have voluntarily consented to the use of subject data by signing the informed consent form
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity to the active ingredient or additives of Rezurock 2. Patients who have received Rezurock for purposes other than those approved in South Korea 3. Patients contraindicated for treatment according to South Korean approval
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All adverse events (AEs) and adverse drug reactions (ADRs) occurring in routine clinical settings: The incidence rate, severity, seriousness, causality, related actions, and progress of adverse events will be described and presented.; Serious adverse events and adverse drug reactions (SAEs/SADRs), Unexpected adverse events and adverse drug reactions not reflected in precautions for use (unexpected AEs/ADRs), Known adverse drug reactions, Non-serious adverse drug reactions, Other safety-related information | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) ;Organ-specific cGVHD response assessment;Time to treatment discontinuation (TTD);Corticosteroid/calcineurin inhibitor (CNI) dose modification and discontinuation rate;The Modified 7-day Lee Symptom Scale (mLSS);Failure-free survival (FFS) | — |
Countries
Korea, Republic of
Contacts
Public ContactJae-Sook Ahn
Chonnam National University Hospital Hwasun Hospital
Outcome results
None listed