✓ Translated by DotMD AI Clinical Council Source: Medicine • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #37335745 ↗

Phase III Randomized Trial: Comparison of prophylactic effects for chemotherapy induced neutropenia between same-day versus next-day administration of pegteograstim (Neurapeg®) in patients treated with chemotherapy regimen composed of day 1 intensive myleosuppressive agent (N = 160)

Original Paper Title: “Comparison of prophylactic effects for chemotherapy induced neutropenia between same-day versus next-day administration of pegteograstim (Neurapeg®) in patients treated with chemotherapy regimen composed of day 1 intensive myleosuppressive agent: A randomized phase III clinical trial”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
N = 160
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • In order to verify non-inferiority of 0.6 days, we estimated a significance level of 5%, power of 80%, and drop-out rate of 15%. This results in the need for a total of 160 patients, 80 in each group.
  • Study Design & Sample: Phase III Randomized Trial published in Medicine (N = 160 human participants).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Medicine (2023), this phase iii randomized trial evaluating 160 human participants investigated: Administration of pegylated granulocyte-colony-stimulating factor (peg-GCSF) 24 to 72 hours after chemotherapy is usually recommended. Key clinical takeaway: In order to verify non-inferiority of 0.6 days, we estimated a significance level of 5%, power of 80%, and drop-out rate of 15%. This results in the need for a total of 160 patients, 80 in each group.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Medicine, 2023-05-19; N = 160; Rigor 82/100): In order to verify non-inferiority of 0.6 days, we estimated a significance level of 5%, power of 80%, and drop-out rate of 15%. This results in the need for a total of 160 patients, 80 in each group.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: gold-bond-intensive-relief-anti-itch-pramoxine-hydrochloride-menthol → Condition: neutropenia → Condition: malignant-neoplasm-of-lower-lobe-right-bronchus-or-lung → Condition: malignant-neoplasm-of-lower-lobe-left-bronchus-or-lung →
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