Evaluation of Reporting of Antibody-Drug Conjugate Associated Sepsis-related Toxicities

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Evaluation of Reporting of Antibody-Drug Conjugate Associated Sepsis-related Toxicities Using International Pharmacovigilance Database

Conditions
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Sepsis (SMQ), Opportunistic Infections, Agranulocytosis

Intervention / Treatment
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* Drug: Antibody-Drug Conjugate
* Drug: Antineoplastic and immunomodulating agents other than Antibody-Drug Conjugate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Antibody-Drug Conjugate (ADC)<br>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<br>* 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.<br>|
| Common cancer drug therapies other than ADC<br>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<br>* We would like to include other common cancer drug therapies such as chemotherapy, targeted therapy, immunotherapy and so on as a comparator group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Case reported in the FDA Adverse Event Reporting System (FAERS) and other international pharmacovigilance database of individual safety case reports to 12/31/2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causality assessment of reported cardiovascular events according to the WHO system |  | 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 |  | 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 |  | 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 |  | 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 |  | Case reported in the FDA Adverse Event Reporting System (FAERS) and other international pharmacovigilance database of individual safety case reports to 12/31/2022 |