{"doi":"10.1136/esmoopen-2016-000148","title":"Patient-reported tolerability of adverse events in phase 1 trials","abstract":null,"journal":"ESMO Open","year":2017,"id":618174,"datarank":0.5101796072493234,"base_score":3.4011973816621555,"endowment":3.4011973816621555,"self_citation_contribution":0.5101796072493234,"citation_network_contribution":0.0,"self_endowment_contribution":0.5101796072493234,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":29,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":589318,"name":"Delphine Lissa","orcid":"0000-0002-1684-5134","position":1,"is_corresponding":false},{"id":1594552,"name":"Xavier Paoletti","orcid":null,"position":2,"is_corresponding":false},{"id":1594553,"name":"Constance Thibault","orcid":null,"position":3,"is_corresponding":false},{"id":88327,"name":"Christophe Le Tourneau","orcid":"0000-0001-9772-4686","position":4,"is_corresponding":false},{"id":130064,"name":"Emilie Lanoy","orcid":null,"position":5,"is_corresponding":false},{"id":258837,"name":"Antoine Hollebecque","orcid":"0000-0003-2869-7551","position":6,"is_corresponding":false},{"id":861958,"name":"Christophe Massard","orcid":"0000-0001-5505-0564","position":7,"is_corresponding":false},{"id":91579,"name":"Jean-Charles Soria","orcid":null,"position":8,"is_corresponding":false},{"id":1594554,"name":"Sophie Postel-Vinay","orcid":null,"position":9,"is_corresponding":false},{"id":882078,"name":"Clémence Henon","orcid":"0000-0001-7893-3116","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Patient-reported tolerability of adverse events in phase 1 trials","abstract":"BACKGROUND: Phase I experts recommend revisiting dose-limiting toxicity (DLT) definition to include chronic and cumulative toxicities induced by new molecularly targeted therapies. Patient's assessment of late toxicities' tolerability is, however, unknown. MATERIALS AND METHODS: A prospective survey on adverse events (AEs) tolerability on 23 National Cancer InstituteCommon Terminology Criteria for Adverse Event, Version 4 (NCI-CTCAE.v4) items was conducted at Gustave Roussy's Phase I department. Patients' maximum tolerability duration was recorded at baseline, during trial and at trial completion. Results were compared with the corresponding physicians' survey. RESULTS: 52 patients enrolled in 27 Phase I trials between May 2014 and November 2015 completed 102 forms. At baseline, the most feared G2/G3 AEs were haematuria (74%), vomiting (71%) and hyperglycemia (64%)/dry mouth (94%), hyperglycemia (92%) and vomiting (92%). At trial completion, the most feared G2/G3 AEs were personality change (83.3%), haematuria (82%) and fever (80%)/dry mouth, fever and dizziness (100% each). Tolerability score did not differ over time. More previous treatments and occurrence of severe AEs were associated with better tolerability at study completion (p=0.0234 and p=0.0153, respectively, in multivariate analysis). Patient's tolerability differed from physician's assessment. CONCLUSION: AEs considered intolerable by patients are toxicities that directly impact their quality of life and differ from those feared by physicians or included in DLT definition. Patient-reported tolerability of AEs may help in optimising drug development.","is_dataset_classified":null,"base_score":3.4011973816621555,"endowment":3.4011973816621555,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"28761740","pmcid":"PMC5519806","openalex_id":"https://openalex.org/W2676545322","authors":[],"funders":[],"total_grants":0,"fwci":1.9092,"citation_percentile":0.89296801,"influential_citations":0,"citation_trend":[{"year":2018,"count":2},{"year":2019,"count":4},{"year":2020,"count":3},{"year":2021,"count":2},{"year":2022,"count":5},{"year":2023,"count":6},{"year":2024,"count":3},{"year":2025,"count":3},{"year":2026,"count":1}],"oa_status":"gold","license":"cc-by-nc-nd","oa_locations":[{"url":"https://esmoopen.bmj.com/content/esmoopen/2/2/e000148.full.pdf","host_type":"journal"},{"url":"https://esmoopen.bmj.com/content/esmoopen/2/2/e000148.full.pdf","host_type":"publisher"},{"url":"https://api.elsevier.com/content/article/PII:S2059702920324455?httpAccept=text/xml","host_type":"publisher"},{"url":"https://api.elsevier.com/content/article/PII:S2059702920324455?httpAccept=text/plain","host_type":"publisher"},{"url":"https://syndication.highwire.org/content/doi/10.1136/esmoopen-2016-000148","host_type":"publisher"},{"url":"https://doi.org/10.1136/esmoopen-2016-000148","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/28761740","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/5519806","host_type":"repository"},{"url":"https://europepmc.org/articles/PMC5519806","host_type":"Europe_PMC"},{"url":"https://europepmc.org/articles/PMC5519806?pdf=render","host_type":"Europe_PMC"}],"fields_of_study":["Statistical Methods in Clinical Trials","Ethics in Clinical Research","Biomedical Ethics and Regulation"],"mesh_terms":[],"keywords":["Tolerability","Medicine","Adverse effect","Common Terminology Criteria for Adverse Events","Nausea","Internal medicine","Vomiting","Clinical trial","Phase 1","Patient Reported Outcome","Adverse Event","Dose Limiting Toxicity"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-03T03:39:29.526181Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}