NCT05349383

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24,618 (actual)
• Sponsor: Central South University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis (SMQ)
• Opportunistic Infections
• Agranulocytosis

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2022-04-22
• Primary completion: 2022-05-22
• Completion: 2022-06-01
• First posted: 2022-04-27
• Last updated: 2022-06-22

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study