Health Condition 1: B44- Aspergillosis Health Condition 2: B40- Blastomycosis Health Condition 3: B37- Candidiasis Health Condition 4: B38- Coccidioidomycosis Health Condition 5: B45- Cryptococcosis Health Condition 6: B39- Histoplasmosis Health Condition 7: B55- Leishmaniasis Health Condition 8: B552- Mucocutaneous leishmaniasis Health Condition 9: B465- Mucormycosis, unspecified Health Condition 10: B49- Unspecified mycosis
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Gilead Sciences Inc
Pharmaceutical Research Associates India Private Limited and ICON Clinical Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male or female patient older than 1 month (inclusive) at the time AmBisome treatment was started 2) Patients who have commenced treatment with AmBisome in accordance with the local routine clinical practice at any time between 01 June 2021 and 30 September 2022 (inclusive)
Exclusion criteria
Exclusion criteria: 1) Patients treated by AmBisome in the framework of a clinical study 2) Patients who initiated treatment with other amphotericin B products, including liposomal amphotericin B products 3) Patients who initiated AmBisome treatment but switched to other amphotericin B products, including other liposomal amphotericin B products, due to non-clinical reasons (e.g. supply issues)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is to evaluate the safety of AmBisome among pediatric and adult patients treated in India in accordance with the local routine clinical practice. This will be descriptive stats only, so we will describe all safety events occurring during the observation period.Timepoint: There is no specific time point to assess the outcome, as this is a retrospective non-interventional study to describe the safety profile of AmBisome in real-life setting. Only descriptive statistics will be used, describing all types of safety events collected throughout the study duration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactDr Rahul Bargaje
Gilead Sciences India Pvt. Ltd
Outcome results
None listed