An observational study in Sepsis (SMQ), Opportunistic Infections and Agranulocytosis, sponsored by Central South University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by Central South University · Observational
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 septic shock. Today, data about sepsis/septic shock are scarce.
The objective was to investigate reports of sepsis/septic shock adverse events related to ADC, including 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 using international pharmacovigilance databases such as the FDA Adverse Event Reporting System (FAERS).
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 toxicities related to ADC.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 24,618 is above the median of 160 across 931 observational studies indexed under Sepsis.
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Cancer patients treated with antibody-drug conjugate and experiencing sepsis-related toxicities.
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 Criteria:
Chronology not compatible between ADC and adverse event (sepsis-related toxicities)
Sepsis-related toxicities induced by antibody-drug conjugate(ADC). Case reported in the FDA Adverse Event Reporting System (FAERS) of Sepsis-related toxicities of patient treated by ADC, with a chronology compatible with the drug toxicity Intervention: Drug: ADC
Drug: Antibody-Drug Conjugate
Sepsis-related toxicities induced by Common cancer drug therapies other than ADC. Case reported in the FDA Adverse Event Reporting System (FAERS) of Sepsis-related toxicities of patient treated by Common cancer drug therapies other than ADC, with a chronology compatible with the drug toxicity Intervention: Drug: Chemotherapy, targeted therapy, immunotherapy and so on.
Drug: Antineoplastic and immunomodulating agents other than Antibody-Drug Conjugate
Compared the case reporting of sepsis-related toxicities among ADC and other common cancer drug therapies. ADC:including 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.
We would like to include other common cancer drug therapies such as chemotherapy, targeted therapy, immunotherapy and so on as a comparator group.
Sepsis-related toxicity of antibody-drug conjugate.
Identification and report of the sepsis-related toxicity of ADC. The research includes the report with MedDRA terms: Sepsis(SMQ), agranulocytosis(SMQ), Opportunistic infections (SMQ). Drugs investigated are ADC: 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.
Time frame: Case reported in the FDA Adverse Event Reporting System (FAERS) and other international pharmacovigilance database of individual safety case reports to 12/31/2022
Causality assessment of reported cardiovascular events according to the WHO system
Time frame: Case reported in the FDA Adverse Event Reporting System (FAERS) and other international pharmacovigilance database of individual safety case reports to 12/31/2022
Description of the type of sepsis-related toxicities depending on the category of ADC
Time frame: Case reported in the FDA Adverse Event Reporting System (FAERS) and other international pharmacovigilance database of individual safety case reports to 12/31/2022
Description of the drug-drug interactions associated with sepsis-related adverse events
Time frame: Case reported in the FDA Adverse Event Reporting System (FAERS) and other international pharmacovigilance database of individual safety case reports to 12/31/2022
Description of the population of patients having a sepsis-related adverse events
Time frame: Case reported in the FDA Adverse Event Reporting System (FAERS) and other international pharmacovigilance database of individual safety case reports to 12/31/2022
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
Time frame: Case reported in the FDA Adverse Event Reporting System (FAERS) and other international pharmacovigilance database of individual safety case reports to 12/31/2022
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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