Extravasations of Anthracycline Anti-cancer Agents
Conditions
Keywords
Extravasation, Anthracyclines
Brief summary
The purpose of this study is to evaluate the efficacy and safety of KDX-0811(Dexrazoxane) in the treatment of accidental extravasation of anthracycline anti-cancer agents.
Interventions
DRUGDexrazoxane
Sponsors
Kissei Pharmaceutical Co., Ltd.
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Inclusion criteria
* Patients suspected to have been exposed to extravasation of anthracycline
Exclusion criteria
* Patients reasonably suspected to have been exposed to extravasation by other compounds than anthracyclines through the same IV access, e.g. vincristine, mitomycin, and vinorelbine, all of which may cause ulceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 4 weeks | Number of participants experienced adverse events |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexrazoxane | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Dexrazoxane |
|---|---|
| Age, Customized >=20 and <65 years | 1 participants |
| Age, Customized >=65 years | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
Adverse Events
Number of participants experienced adverse events
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexrazoxane | Adverse Events | 2 participants |