ArticleHealth science reports2026
The Real-World Safety Profile of Immune Checkpoint Inhibitors in Melanoma: FAERS Pharmacovigilance Analysis Complemented by Randomized Trial Evidence.
Article in Health science reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background and Aims: Melanoma can be effectively treated with immune checkpoint inhibitors (ICIs), but information regarding the risks of treatment-related adverse events (trAEs), immune-related adverse events (irAEs), and real-world adverse events (AEs) is scarce. Methods: We searched PubMed, Embase, Medline, and Cochrane CENTRAL databases for randomized controlled trials (RCTs) comparing ICIs for melanoma therapy up to February 16, 2025. Bayesian network meta-analysis (NMA) was conducted, and odds ratios (ORs) with 95% credible intervals (95%CrI) were calculated. A pharmacovigilance analysis was performed using the Food and Drug Administration Adverse Event Reporting System (FAERS) database. ICI-associated AEs in patients with melanoma were obtained for the period from the first quarter (Q1) of 2004 to Q1 of 2023. Results: The NMA included 31 RCTs, comprising 11,937 patients with melanoma. Ipilimumab (Ipi), nivolumab (Nivo), and pembrolizumab (Pem) were ranked as having the lowest risk of any grade as well as grade 3-5 trAEs. Chemotherapy (Chemo) was associated with the lowest risk of any grade or grade 3-5 irAEs. Compared to other ICIs, Chemo, Ipi, and Ipi-Chemo were associated with the lowest risk of any irAEs. Based on the results of the FAERS pharmacovigilance analysis, we identified 5974 AEs in 4599 melanoma patients treated with ICIs. ICIs were associated with statistically significant indications involving 236 preferred terms (PTs). Thoroughly examined and pinpointed AEs were strongly correlated with ICIs. Pem treatment was associated with 166 significant PTs. Apart from malignant neoplasm progression and death, the most common PT was an immune-mediated adverse reaction. Conclusion: The results of this study indicated that ICI safety profiles vary. These findings provide comparative safety signals that may help inform AE monitoring and risk assessment in patients with melanoma receiving ICIs, but they should not be interpreted as definitive prescribing guidance.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.