Sintilimab Myelosuppression Study: Pharmacovigilance and Clinical Cohort Analysis

A 2020-2025 analysis of FDA Adverse Event Reporting System data and a retrospective clinical cohort of 170 patients investigates myelosuppression associated with the PD-1 inhibitor sintilimab. The study, authored by Shiquan Liu and shared on figshare in April 2026, integrates disproportionality analysis and logistic regression to characterize risk, incidence, and predictors of this hematological adverse event.

Use Cases

• Validate pharmacovigilance signals for drug safety based on FAERS disproportionality analysis results.
• Model time-to-onset of adverse events based on the described Weibull distribution analysis.
• Identify patient risk factors for myelosuppression based on the described logistic regression findings.
• Benchmark real-world incidence rates of severe adverse events based on the described clinical cohort data.

Strengths

• Integrates two complementary data sources: 668 FAERS reports and a clinical cohort of 170 patients.
• 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 primary data file is a 44.0 KB DOCX document, which likely contains a study manuscript rather than raw, structured datasets.
• Row counts and column-level documentation for any underlying tabular data are unknown.
• The clinical cohort data is from a single center, which may limit generalizability.

Provenance

Source

figshare

Collection Method

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

Time Range

Q1 2020 to Q2 2025 for FAERS data.

Freshness

Last updated 2026-04-10 05:59:12.

Geography

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