Fatal events during clinical trials: an evaluation of deaths during breast cancer studies.
Adult
Aged
Aged, 80 and over
Anthracyclines
/ adverse effects
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Autopsy
Body Mass Index
Breast Neoplasms
/ drug therapy
Bridged-Ring Compounds
/ adverse effects
Comorbidity
Female
Germany
Heart Failure
/ complications
Humans
Middle Aged
Patient Safety
Pneumonia
/ complications
Prospective Studies
Pulmonary Embolism
/ complications
Randomized Controlled Trials as Topic
Risk Factors
Sepsis
/ complications
Taxoids
/ adverse effects
Cause of death
Chemotherapy-related death
Death in clinical trial
Rate of autopsy
Serious adverse events
Journal
Breast cancer (Tokyo, Japan)
ISSN: 1880-4233
Titre abrégé: Breast Cancer
Pays: Japan
ID NLM: 100888201
Informations de publication
Date de publication:
Nov 2019
Nov 2019
Historique:
received:
14
03
2019
accepted:
14
06
2019
pubmed:
30
6
2019
medline:
27
2
2020
entrez:
30
6
2019
Statut:
ppublish
Résumé
Information on deaths occurring during oncological clinical trials has never been systematically assessed. Here, we examine the incidence of death and the profile of patients who died during randomized clinical breast cancer (BC) trials. Information on fatal events during German Breast Group (GBG) led BC trials was prospectively captured. Data were derived from the trial databases and death narratives. All deaths were evaluated for possible causes, underlying conditions, treatment relatedness, time point and rate of autopsies. From 12/1996 to 01/2017, 23,387 patients were treated within 32 trials. Of those 88 (0.4%) died on therapy within 17 trials. Median age was 64 [range 35-84] years, 63.2% of patients had a body mass index (BMI) ≥ 25 kg/m Death during study treatment was mainly related to infections, and patients with advanced disease, high BMI, underlying comorbidities, CRFs and concomitant medications. If considered for study participation these patients need careful monitoring due to their higher risk for death on study.
Sections du résumé
BACKGROUND
BACKGROUND
Information on deaths occurring during oncological clinical trials has never been systematically assessed. Here, we examine the incidence of death and the profile of patients who died during randomized clinical breast cancer (BC) trials.
METHODS
METHODS
Information on fatal events during German Breast Group (GBG) led BC trials was prospectively captured. Data were derived from the trial databases and death narratives. All deaths were evaluated for possible causes, underlying conditions, treatment relatedness, time point and rate of autopsies.
RESULTS
RESULTS
From 12/1996 to 01/2017, 23,387 patients were treated within 32 trials. Of those 88 (0.4%) died on therapy within 17 trials. Median age was 64 [range 35-84] years, 63.2% of patients had a body mass index (BMI) ≥ 25 kg/m
CONCLUSIONS
CONCLUSIONS
Death during study treatment was mainly related to infections, and patients with advanced disease, high BMI, underlying comorbidities, CRFs and concomitant medications. If considered for study participation these patients need careful monitoring due to their higher risk for death on study.
Identifiants
pubmed: 31254201
doi: 10.1007/s12282-019-00990-3
pii: 10.1007/s12282-019-00990-3
doi:
Substances chimiques
Anthracyclines
0
Bridged-Ring Compounds
0
Taxoids
0
taxane
1605-68-1
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM