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

A study integrating pharmacovigilance and clinical data to investigate myelosuppression risk associated with the PD-1 inhibitor sintilimab. It analyzes 668 reports from the FDA Adverse Event Reporting System (FAERS) from Q1 2020 to Q2 2025 and a retrospective clinical cohort of 170 patients. The dataset was authored by Shiquan Liu and last updated on figshare in April 2026.

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 myelosuppression based on the LASSO and logistic regression findings
• Assess the incidence and severity of hematological toxicity in a real-world clinical cohort

Strengths

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

Limitations

• Column-level documentation is absent; field semantics must be inferred after download
• Row count for the underlying tabular data is unknown, which may limit suitability assessment
• The clinical cohort is from a single center, which may limit generalizability

Provenance

Source

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

Collection Method

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

Time Range

Q1 2020 to Q2 2025 for FAERS data.

Freshness

Last updated 2026-04-10 05:59:10; freshness should be verified

Geography

Clinical cohort geography is unspecified; likely reflects bias inherent to the single-center source.