Impact of open-label versus blinded study design on patient-reported outcomes data in randomized clinical trials of immunotherapy in advanced or metastatic cancer …

A Anota, A Pozet, H Lemasson, FE Cotté, A Falcoz… - Quality of Life …, 2022 - Springer
… In our review, baseline PRO scores were also reported in majority of trials and particularly
in … have been published including data from the PACIFIC open-label phase III trial exploring …

Patient-reported outcomes with atezolizumab plus bevacizumab versus sorafenib in patients with unresectable hepatocellular carcinoma (IMbrave150): an open-label …

PR Galle, RS Finn, S Qin, M Ikeda, AX Zhu… - The Lancet …, 2021 - thelancet.com
… of associations between selected PRO scale scores and … from baseline in patient-reported
outcomes and lower risk of … increase in patient-reported outcome scores obtained from …

Prognostic value of patient-reported outcomes from international randomised clinical trials on cancer: a systematic review

J Mierzynska, C Piccinin, M Pe, F Martinelli… - The Lancet …, 2019 - thelancet.com
… , we searched the references of selected papers and consulted … the generalisability of PRO
results to the whole trial population. … Analysis of a randomized phase III trial of the cancer and …

Patient-reported outcomes from a randomized, active-controlled, open-label, phase 3 trial of burosumab versus conventional therapy in children with X-linked …

R Padidela, MP Whyte, FH Glorieux, CF Munns… - Calcified tissue …, 2021 - Springer
… the phase 3 pediatric trial using Patient-Reported Outcomes … the PRO results from the
phase 3 pediatric trial, specifically … was created by selecting items from the three pediatric item …

Patient-reported outcomes from the randomized phase 3 CROWN study of first-line lorlatinib versus crizotinib in advanced ALK-positive non-small cell lung cancer

J Mazieres, L Iadeluca, AT Shaw, BJ Solomon… - Lung Cancer, 2022 - Elsevier
… from randomization to the first time a patient’s score showed a … data, compared with the phase
3 ALEX trial (66 % and 64 % … non-small cell lung cancer in the global phase III ALEX study …

Patient-reported outcomes in randomised clinical trials of bladder cancer: an updated systematic review

M Van Hemelrijck, F Sparano, D Josephs, M Sprangers… - BMC urology, 2019 - Springer
… Little improvement into the uptake and assessment of PRO as an outcome in RCTs for BC
… We thus rated each RCT with a score ranging from 0 to a maximum of 18 (RCT with PRO as …

… of life outcomes in patients with resected epidermal growth factor receptor–mutated non–small cell lung cancer who received adjuvant osimertinib in the phase III …

M Majem, JW Goldman, T John, C Grohe… - Clinical Cancer …, 2022 - AACR
… with stage II–IIIA NSCLC, and select patients with stage IB … HRQoL scores in Chinese patients
with resected stage II–IIIA … treatments and crossover to open-label osimertinib. Finally, the …

Patient-reported outcomes from the phase 3 ADMIRAL trial in patients with FLT3-mutated relapsed/refractory AML

EK Ritchie, D Cella, F Fabbiano, A Pigneux… - Leukemia & …, 2023 - Taylor & Francis
… (PROs) can inform treatment selection and assess treatment … ADMIRAL was a phase 3,
open-label, multicenter, randomizedscore and two sub-scores that assess fatigue severity across …

1556MO The iBLAD study: Patient-reported outcomes in bladder cancer during oncological treatment: A multicenter national randomized controlled trial

GA Taarnhøj, C Johansen, A Carus… - Annals of …, 2022 - annalsofoncology.org
results of a randomized controlled trial (RCT) of PROs in patients with muscle-invasive or
metastatic bladder cancer (BC… Patients were randomized 1:1 between answering selected PRO…

Patient-Reported Outcomes From the Phase III HIMALAYA Study of Tremelimumab Plus Durvalumab in Unresectable Hepatocellular Carcinoma

B Sangro, PR Galle, RK Kelley… - Journal of Clinical …, 2024 - ascopubs.org
… to assess HRQoL in cancer clinical trials, and its HCC-specific … , which are less prone to
open-label bias. Furthermore, … indicate that open-label bias did not affect these findings. Another …