Status:
COMPLETED
Evaluation of Reporting of Antibody-Drug Conjugate Associated Sepsis-related Toxicities
Lead Sponsor:
Central South University
Conditions:
Sepsis (SMQ)
Opportunistic Infections
Eligibility:
All Genders
Brief Summary
Although antibody-drug conjugate(ADC) has proved effective in treating many cancers, few patients receiving ADC may experience rare but life-threatening sepsis-related toxicities such as sepsis and se...
Detailed Description
Here, investigators use international pharmacovigilance databases such as the FDA Adverse Event Reporting System (FAERS) of individual safety case reports, to identify cases of sepsis-related toxiciti...
Eligibility Criteria
Inclusion
- Case reported in the FDA Adverse Event Reporting System (FAERS) or other international pharmacovigilance database of individual safety case reports to 12/31/2022 Adverse event reported were included the report with MedDRA terms: Sepsis(SMQ), agranulocytosis(SMQ), Opportunistic infections (SMQ).
- Patients treated with ADC included: Gemtuzumab Ozogamicin, Trastuzumab Emtansine, Inotuzumab Ozogamicin, Enfortumab vedotin, Trastuzumab deruxtecan, Sacituzumab govitecan, Brentuximab Vedotin, Moxetumomab pasudotox, Polatuzumab Vedotin, Belantamab Mafodotin, loncastuximab tesirine and Tisotumab vedotin. Other cancer patients received common drug therapies such as chemotherapy, targeted therapy or immunotherapy would also be included as a comparator.
Exclusion
- Chronology not compatible between ADC and adverse event (sepsis-related toxicities)
Key Trial Info
Start Date :
April 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
24618 Patients enrolled
Trial Details
Trial ID
NCT05349383
Start Date
April 22 2022
End Date
June 1 2022
Last Update
June 22 2022
Active Locations (1)
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1
Central South University
Changsha, Hunan, China, 410000