ArticleJournal for immunotherapy of cancer2018
Serious adverse events and fatal adverse events associated with nivolumab treatment in cancer patients : Nivolumab-related serious/fatal adverse events.
Article in Journal for immunotherapy of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 23 papers, 4 of them syntheses that pooled it.
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
23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- A system review of neoadjuvant immune checkpoint blockade for breast cancer.Frontiers in immunology · 2025Pooled it
- Meta-analysis of immune-related adverse events of immune checkpoint inhibitor therapy in cancer patients.Thoracic cancer · 2020Pooled it
- Incidence and Risk of Fatal Adverse Events in Cancer Patients Treated With Vascular Endothelial Growth Factor Receptor 2-Targeted Agents: A Meta-Analysis With Trial Sequential Analysis of Randomized Controlled Trials.Frontiers in medicine · 2019Pooled it
- Antitumor Activity and Treatment-Related Toxicity Associated With Nivolumab Plus Ipilimumab in Advanced Malignancies: A Systematic Review and Meta-Analysis.Frontiers in pharmacology · 2019Pooled it
- Nivolumab Versus Gemcitabine or Pegylated Liposomal Doxorubicin for Patients With Platinum-Resistant Ovarian Cancer: Open-Label, Randomized Trial in Japan (NINJA).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021Trial
- Aseptic meningitis induced by monoclonal antibodies used in cancer treatment: a systematic review.Research in pharmaceutical sciences · 2026Review
- HLA-DRB3/4/5-based susceptibility profiles in nivolumab-induced type 1 diabetes and interstitial lung disease.Frontiers in immunology · 2026Article
- Nivolumab-Induced Refractory Hemorrhagic Gastritis and Duodenitis Requiring Multimodal Biologic Therapy.ACG case reports journal · 2025Article
- Safety of immune checkpoint inhibitors for cancer treatment: real-world retrospective data analysis from Qatar (SAFE-ICI-Q study).Frontiers in immunology · 2025Article
- Nivolumab Safety in Renal Cell Carcinoma: A Case Report.The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians · 2024Article
- Depression and anxiety in cancer patient enrolled in clinical trials with serious adverse events.Cancer medicine · 2023Article
- Article
- Pulmonary adverse events following immune checkpoint inhibitors.Current opinion in pulmonary medicine · 2022Review
- Molecular Mechanisms of PD-1 and PD-L1 Activity on a Pan-Cancer Basis: A Bioinformatic Exploratory Study.International journal of molecular sciences · 2021Article
- Invasive Fungal Diseases in Children with Hematological Malignancies Treated with Therapies That Target Cell Surface Antigens: Monoclonal Antibodies, Immune Checkpoint Inhibitors and CAR T-Cell Therapies.Journal of fungi (Basel, Switzerland) · 2021Review
- Fatal adverse events associated with programmed cell death protein 1 or programmed cell death-ligand 1 monotherapy in cancer.Therapeutic advances in medical oncology · 2020Article
- Fatal myositis and spontaneous haematoma induced by combined immune checkpoint inhibitor treatment in a patient with pancreatic adenocarcinoma.BMC cancer · 2019Article
- The dark side of immunotherapy: challenges facing the new hope in cancer treatment.Annals of translational medicine · 2019Article
- Treatment of inoperable hepatocellular carcinoma with immunotherapy.BMJ case reports · 2019Article
- Targeting Tumor Microenvironment for Cancer Therapy.International journal of molecular sciences · 2019Review
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
3 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNivolumab, an immune checkpoint inhibitor, has revolutionized the treatment of many cancers. Due to its novel mechanisms of action, nivolumab induces a distinct profile of adverse events. Currently, the incidence and risk of developing serious adverse events (SAEs) or fatal adverse events (FAEs) following nivolumab administration are unclear.
methodsWe conducted a systematic search for phase 2 and phase 3 nivolumab trials in PubMed and Embase from inception to June 2018. Data on SAEs/FAEs were extracted from each study and pooled to calculate the overall incidence and odds ratios (ORs).
resultsA total of 21 trials with 6173 cancer patients were included in this study. The overall incidence of SAEs and FAEs with nivolumab were 11.2% (95% CI, 8.7-13.8%) and 0.3% (95% CI, 0.1-0.5%), respectively. The incidence of SAEs varied significantly with cancer type and clinical phase, but no evidence of heterogeneity was found for FAEs. Compared with conventional treatment, the administration of nivolumab did not increase the risk of SAEs (OR, 0.69; 95% CI, 0.34-1.40; p = 0.29) or FAEs (OR, 0.61; 95% CI, 0.27-1.39; p = 0.24). SAEs occurred in the major organ systems in a dispersed manner, with the most common toxicities appearing in the respiratory (21.4%), gastrointestinal (7.7%), and hepatic systems (6.6%). The most common cause of SAEs/FAEs was pneumonitis.
conclusionsAlthough nivolumab is a relatively safe antitumor agent, nononcologists should be advised of the potential adverse events. Additionally, future studies are needed to identify patients at high risk of SAEs/FAEs to aid in the development of optimal monitoring strategies and the exploration of treatments to decrease the risks.
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.