André Rogatko
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View article: Feasibility of frequent monitoring of symptoms using the PRO-CTCAE in the NRG-BR004 clinical trial
Feasibility of frequent monitoring of symptoms using the PRO-CTCAE in the NRG-BR004 clinical trial Open
Background The PRO-CTCAE Measurement System was designed to enhance the quality of the standard toxicity evaluation in clinical trials. We developed a substudy within NRG-BR004, a phase III clinical trial in patients with newly documented …
View article: Methods for randomized, blinded, controlled evaluation of putative disease interventions in multi-laboratory, preclinical assessment networks
Methods for randomized, blinded, controlled evaluation of putative disease interventions in multi-laboratory, preclinical assessment networks Open
Science faces a reproducibility crisis, and public trust in science suffers when large clinical trials—qualified by promising preclinical studies—fail. While some clinical trial designs may have been inadequate, preclinical assessments of …
View article: Dose Finding in Oncology Trials Guided by Ordinal Toxicity Grades Using Continuous Dose Levels
Dose Finding in Oncology Trials Guided by Ordinal Toxicity Grades Using Continuous Dose Levels Open
We present a Bayesian adaptive design for dose finding in oncology trials with application to a first-in-human trial. The design is based on the escalation with overdose control principle and uses an intermediate grade 2 toxicity in additi…
View article: Development of a Web-Based Interactive Tool for Visualizing Breast Cancer Clinical Trial Tolerability Data
Development of a Web-Based Interactive Tool for Visualizing Breast Cancer Clinical Trial Tolerability Data Open
PURPOSE Longitudinal patient tolerability data collected as part of randomized controlled trials are often summarized in a way that loses information and does not capture the treatment experience. To address this, we developed an interacti…
View article: Supplementary Figure S1 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Figure S1 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Figure S1 shows the estimated discontinuation curve in patients treated with anastrozole and tamoxifen, along with the p-value associated with the log-rank test.
View article: Supplementary Figure S7 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Figure S7 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Figure S7 presents a screenshot of the web tool; the supplementary data provides instructions for utilizing the web-based treatment discontinuation predictive tool developed based on the predictive survival models.
View article: Supplementary Methods S2 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Methods S2 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Methods S2 provides a statistical description of the prediction error used to assess the model performance.
View article: Supplementary Table S2 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Table S2 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Table S2 provides information about the number of patients with missing adverse events at each timepoint for anastrozole treatment.
View article: Supplementary Figure S7 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Figure S7 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Figure S7 presents a screenshot of the web tool; the supplementary data provides instructions for utilizing the web-based treatment discontinuation predictive tool developed based on the predictive survival models.
View article: Supplementary Figure S6 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Figure S6 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Figure S6 (a) shows the actual eight PROs of patient 1 at two time points, baseline, and 6 months (shown by the black dotted line). This patient is also overweight at baseline (25 < BMI < 30). In the clinical data set, this p…
View article: Supplementary Table S4 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Table S4 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Table S4 presents the optimal risk thresholds (c) and estimates of diagnostic measures such as sensitivity, specificity, and accuracy, along with their corresponding 95% confidence intervals. These values are derived from the…
View article: Supplementary Figure S3 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Figure S3 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Figure S3 shows the estimated discontinuation curves by training dataset and validation cohort for the tamoxifen-treated patients.
View article: Supplementary Table S3 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Table S3 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Table S3 provides information about the number of patients with missing adverse events at each timepoint for tamoxifen treatment.
View article: Supplementary Figure S4 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Figure S4 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Figure S4 illustrates the estimated time-dependent ROC curves using the PCCox and PCCox BLUP models in the validation cohort for anastrozole treatment. The area under the ROC curve (AUC) and its corresponding 95% confidence i…
View article: Supplementary Methods S1 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Methods S1 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Methods S1 provides a comprehensive statistical description of the two applied predictive survival models (PC Cox model and PC Cox BLUP model).
View article: Supplementary Figure S5 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Figure S5 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Figure S5 illustrates the estimated time-dependent ROC curves using the PCCox and PCCox BLUP models in the validation cohort for tamoxifen treatment. The area under the ROC curve (AUC) and its corresponding 95% confidence int…
View article: Supplementary Figure S4 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Figure S4 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Figure S4 illustrates the estimated time-dependent ROC curves using the PCCox and PCCox BLUP models in the validation cohort for anastrozole treatment. The area under the ROC curve (AUC) and its corresponding 95% confidence i…
View article: Supplementary Figure S2 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Figure S2 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Figure S2 shows the estimated discontinuation curves by training dataset and validation cohort for the anastrozole-treated patients.
View article: Supplementary Table S1 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Table S1 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Table S1 outlines all predictors employed to predict treatment discontinuation, including the predictor variable name, variable description, variable type, and whether the data was collected over time or only at baseline.
View article: Data from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Data from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Predicting an individual's risk of treatment discontinuation is critical for the implementation of precision chemoprevention. We developed partly conditional survival models to predict discontinuation of tamoxifen or anastrozole using pati…
View article: Supplementary Figure S1 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Figure S1 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Figure S1 shows the estimated discontinuation curve in patients treated with anastrozole and tamoxifen, along with the p-value associated with the log-rank test.
View article: Supplementary Figure S5 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Figure S5 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Figure S5 illustrates the estimated time-dependent ROC curves using the PCCox and PCCox BLUP models in the validation cohort for tamoxifen treatment. The area under the ROC curve (AUC) and its corresponding 95% confidence int…
View article: Supplementary Table S2 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Table S2 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Table S2 provides information about the number of patients with missing adverse events at each timepoint for anastrozole treatment.
View article: Supplementary Table S4 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Table S4 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Table S4 presents the optimal risk thresholds (c) and estimates of diagnostic measures such as sensitivity, specificity, and accuracy, along with their corresponding 95% confidence intervals. These values are derived from the…
View article: Supplementary Figure S3 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Figure S3 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Figure S3 shows the estimated discontinuation curves by training dataset and validation cohort for the tamoxifen-treated patients.
View article: Supplementary Methods S2 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Methods S2 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Methods S2 provides a statistical description of the prediction error used to assess the model performance.
View article: Supplementary Methods S1 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Methods S1 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Methods S1 provides a comprehensive statistical description of the two applied predictive survival models (PC Cox model and PC Cox BLUP model).
View article: Supplementary Figure S2 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Figure S2 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Figure S2 shows the estimated discontinuation curves by training dataset and validation cohort for the anastrozole-treated patients.
View article: Supplementary Table S3 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial
Supplementary Table S3 from Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial Open
Supplementary Table S3 provides information about the number of patients with missing adverse events at each timepoint for tamoxifen treatment.