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

668 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 cancer drug sintilimab. The study, authored by Shiquan Liu and uploaded in April 2026, found myelosuppression was the most frequent hematological adverse event, with a strong pharmacovigilance signal (ROR=51.86) and a 67.06% incidence in the clinical cohort.

Use Cases

• Modeling time-to-onset of adverse drug reactions based on Weibull distribution analysis mentioned in the description
• Identifying patient risk factors for drug toxicity based on regression analyses of clinical variables
• Validating pharmacovigilance signals from spontaneous reporting systems with real-world clinical cohort data
• Assessing the severity of hematological adverse events based on CTCAE v5.0 grading criteria

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 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
• The clinical cohort is from a single center, which may limit generalizability
• Row count for the underlying tabular data is unknown, which may limit suitability assessment

Provenance

Source

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

Collection Method

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

Time Range

FAERS data covers Q1 2020 to Q2 2025.

Freshness

Last updated 2026-04-10 05:59:11; freshness should be verified

Geography

Geographic coverage is not specified but likely includes reports submitted to the US FDA.