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

Completed

• Conditions: Opportunistic Infections; Agranulocytosis; Sepsis (SMQ)
• Interventions: Drug: Antibody-Drug Conjugate; Drug: Antineoplastic and immunomodulating agents other than Antibody-Drug Conjugate

• Registration Number: NCT05349383
• Lead Sponsor: Central South University

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 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

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.

Study Timeline

• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-21
• Study Start: 2022-04-22
• Study First Posted: 2022-04-27
• Primary Completion: 2022-05-22
• Status Verified: 2022-06
• Study Completion: 2022-06-01
• Last Update Submitted: 2022-06-19
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24618

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Antibody-Drug Conjugate (ADC)	Antibody-Drug Conjugate	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
Common cancer drug therapies other than ADC	Antineoplastic and immunomodulating agents other than 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.

Primary Outcome Measures

Name	Time	Method
Sepsis-related toxicity of antibody-drug conjugate.	Case reported in the FDA Adverse Event Reporting System (FAERS) and other international pharmacovigilance database of individual safety case reports to 12/31/2022	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.

Secondary Outcome Measures

Name	Time	Method
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 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
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 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

Trial Locations

Locations (1)

Central South University; 🇨🇳 Changsha, Hunan, China