Sintilimab Myelosuppression Risk from FAERS and Clinical Cohort Analysis

A study integrating pharmacovigilance signal mining with real-world clinical evidence to investigate myelosuppression associated with the PD-1 inhibitor sintilimab. The dataset includes 668 FAERS reports from Q1 2020 to Q2 2025 and a retrospective clinical cohort of 170 patients. The analysis was authored by Shiquan Liu and last updated on 2026-04 -10.

Use Cases

• Identify risk factors for drug-induced myelosuppression based on reported patient characteristics and concomitant medications.
• Model time-to-onset of adverse events based on the Weibull distribution analysis described.
• Validate pharmacovigilance signals with real-world incidence and severity data from a clinical cohort.
• Perform disproportionality analysis for adverse event signals based on the reported ROR and PRR methods.

Strengths

• Integrates two data sources: 668 FAERS reports and a 170-patient clinical cohort for validation.
• Reports specific statistical results, including a strong signal (ROR=51.86) and a high incidence rate (67.06%) in the cohort.
• Identifies independent risk factors with odds ratios and p-values, such as paclitaxel use (OR=4.129).

Limitations

• Row count for the underlying data tables is unknown, which may limit suitability assessment.
• 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

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

Collection Method

Disproportionality analyses (ROR, PRR), Weibull distribution modeling, LASSO, and multivariable logistic regression.

Time Range

Q1 2020 to Q2 2025 for FAERS data.

Freshness

Last updated 2026-04-10 05:59:14; freshness should be verified.

Geography

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