Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions
N/A
N/A
N/A
N/A
N/A
Not Enrolling
Both
Breast Neoplasm
Both
Breast Neoplasm
Trial Information
Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions
Patients selected by investigator according to clinical routine
Inclusion Criteria:
- Patients with metastatic breast cancer
Exclusion Criteria:
- History of hypersensitivity to Caelyx or its components
- Women who are pregnant or breast-feeding
- Patients with severe myelosuppression
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Number of Participants With Infusion Reactions (IR)
Outcome Description:
Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.
Outcome Time Frame:
Day 1 up to Week 24
Safety Issue:
Yes
Authority:
Austria: Ethikkommission
Study ID:
P04878
NCT ID:
NCT00736333
Start Date:
November 2006
Completion Date:
June 2010
Related Keywords:
- Breast Neoplasm
- Breast Neoplasms
- Neoplasms
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