Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IV
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
141; 102 | — |
| PRIMARY Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs) |
8 | — |
| PRIMARY Duration of Adverse Events (AEs) |
4.03 | — |
| PRIMARY Number of Adverse Events (AEs) by Severity |
33; 43; 109 | — |
| PRIMARY Number of Participants With Outcome in Response to Adverse Events (AEs) |
106; 7; 28 | — |
| PRIMARY Percentage of Treatment-Emergent Treatment-Related Adverse Events (AEs) |
1.08; 0; 5.95; 92.43; 0; 0.54 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities |
35 | — |
| PRIMARY Number of Participants With Clinical Response (CR) |
88; 89; 19; 3 | — |
| PRIMARY Number of Participants With Mycological Response (MR) |
149; 28; 16; 6; 0; 0 | — |
| PRIMARY Number of Participants With Overall Response (OR) |
173; 26; 0 | — |
Eligibility Criteria
- Prospective Study Population 1.1. Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Use in the treatment of invasive candidiasis in adult patients
- Evidence of a personally signed and dated data privacy statement indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
1.2. Exclusion Criteria
Subjects presenting with any of the following will not be included in the study:
- Subjects to whom Eraxis IV is prescribed for other diseases than invasive candidiasis in adult patients.
- Subjects less than 18 ages should be excluded in this study since safety and effectiveness in pediatric patients have not been established yet.
- Hypersensitivity to the active substance, or to any of the excipients.
- Hypersensitivity to other medicinal products of the echinocandin class (e.g. caspofungin).
- Retrospective Study Population 2.1. Inclusion Criteria
Subjects must meet one of the following inclusion criteria to be eligible for enrollment into the study:
Since all subjects enrolled should meet the usual prescribing criteria as per the local product document of Eraxis IV at the time of starting Eraxis IV administration, the inclusion criteria is divided as followings on the basis of 10 Mar 2015 when the approved indication was updated.
- In case where the starting date of Eraxis IV administration is prior to 10 Mar 2015 - Use in the treatment of the following fungal infections: candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis)
- In case where the starting date of Eraxis IV administration is 10 Mar 2015 or after - Use in the treatment of invasive candidiasis in adult patients 2.2. Exclusion Criteria
Subjects presenting with any of the following will not be included in the study:
- Subjects to whom Eraxis IV was prescribed for other diseases than candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis) (in case where the starting date of Eraxis IV administration is prior to 10 Mar 2015) or invasive candidiasis in adult patients (in case where the starting date of Eraxis IV administration is 10 Mar 2015 or after).
- Subjects less than 18 ages should be excluded in this study since safety and effectiveness in pediatric patients have not been established yet.
- Hypersensitivity to the active substance, or to any of the excipients.
- Hypersensitivity to other medicinal products of the echinocandin class (e.g. caspofungin).
- Subjects enrolled in the prospective phase study.
Data sourced from ClinicalTrials.gov (NCT00802854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.