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

Opportunistic Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349383
• Other study ID #: CSU20220499
• Status: Completed
• Start date: April 22, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24618
• Est. completion date: June 1, 2022
• Est. primary completion date: May 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Agranulocytosis
• Opportunistic Infections
• Sepsis
• Toxemia

Intervention

Drug:
• 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.
• Antineoplastic and immunomodulating agents other than Antibody-Drug Conjugate
We would like to include other common cancer drug therapies such as chemotherapy, targeted therapy, immunotherapy and so on as a comparator group.

Locations

Country	Name	City	State
China	Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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