Sintilimab Myelosuppression Risk: FAERS and Clinical Cohort Analysis, 2020-2025

668 adverse event reports from the FDA Adverse Event Reporting System (FAERS) and a retrospective clinical cohort of 170 patients were analyzed to investigate myelosuppression associated with the PD-1 inhibitor sintilimab. The study, authored by Shiquan Liu and last updated in April 2026, found myelosuppression was the most frequent hematological adverse event, with a strong pharmacovigilance signal and a 67.06% incidence in the clinical cohort.

Use Cases

• Validate pharmacovigilance signals for drug safety based on disproportionality analysis results mentioned in the description
• Model time-to-onset of adverse events based on the Weibull distribution analysis described
• Identify patient risk factors for severe adverse events based on the logistic regression results for sex, chemotherapy use, and disease stage
• Benchmark real-world incidence rates of drug toxicity against clinical trial data based on the reported cohort statistics

Strengths

• Integrates two data sources: 668 FAERS reports and a clinical cohort of 170 patients for validation
• Provides specific statistical results, including a Reporting Odds Ratio of 51.86 and a median onset time of 14 days
• Identifies concrete risk factors with odds ratios, such as paclitaxel use (OR=4.129) and female sex (OR=0.457)

Limitations

• The dataset is a single 11.1 KB DOCX file, indicating a very limited scope, likely containing summary tables and text rather than raw patient-level data
• Column-level documentation is absent; field semantics must be inferred after download
• The clinical cohort is from a single center, which may limit generalizability

Provenance

Source

Analysis of FDA Adverse Event Reporting System (FAERS) data and a single-center retrospective cohort.

Collection Method

Disproportionality analysis, Weibull distribution modeling, and LASSO/multivariable logistic regression.

Time Range

Q1 2020 to Q2 2025 for FAERS data.

Freshness

Last updated 2026-04-10 05:59:13

Geography

null