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Are Serious Adverse Events Associated with CTCAE Grade 4 and 5?

  Short answer: SAEs and CTCAE grades are related but not equivalent . Grade 4 and Grade 5 events often qualify as SAEs, but CTCAE grade ≠ seriousness , and neither automatically determines the other. 🔍 How They Differ 1. CTCAE Grade = Severity CTCAE grades reflect clinical severity , regardless of outcome. Grade 4 = Life‑threatening consequences; urgent intervention needed Grade 5 = Death related to AE This is a severity scale , not a regulatory classification. 2. Seriousness (SAE) = Regulatory outcome FDA/ICH define a serious adverse event based on outcomes, such as: Results in death Life‑threatening Requires hospitalization or prolongation Causes disability Congenital anomaly Other medically important conditions This is not based on severity but on impact on patient safety and regulatory reporting . ✅ Relationship Between Them ✔ Grade 5 (death) Always an SAE. Death is inherently a serious outcome → automatically classified as SAE. ✔ Grade 4 (life‑threatening) Almost always...
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Introduction to RECIST 1.1 (4)

Navigating the "Nadir": A Guide to Progressive Disease (PD) in RECIST 1.1 In cancer clinical trials, determining when a treatment has stopped working is just as important as knowing when it is succeeding . Under the RECIST 1.1 guidelines, this transition is captured by the term Progressive Disease (PD) . To understand how PD is derived, you must first understand a concept called the Nadir . What is the Nadir? The nadir is the "all-time low" for a patient's tumor burden during the study. Initial Reference: At the start of a trial, the Baseline Sum of Diameters is the first nadir . Dynamic Updating: If the tumors shrink during treatment, the new, smaller sum of diameters becomes the updated nadir . The "Smallest on Study" Rule: The nadir is always the smallest sum of diameters recorded at any assessment since the beginning of the trial . The Two-Part Rule for PD To declare Progressive Disease based on target lesions, the current sum of diameters mu...
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Introduction to RECIST 1.1 (1)

Based on the revised RECIST 1.1 guidelines, the derivation of overall response depends on the classification of disease at baseline and the evaluation of three distinct categories: target lesions , non-target lesions , and the appearance of new lesions . 1. Categorization of Lesions at Baseline To determine response, overall tumor burden must be estimated at baseline : Target Lesions: Up to a maximum of five measurable lesions total (and no more than two per organ) are identified to be followed quantitatively . A " sum of diameters" is calculated for these lesions . Non-Target Lesions: All other disease sites, including non-measurable lesions and pathological lymph nodes not selected as target lesions, are recorded qualitatively . Measurability: N on-nodal lesio ns are measurable if they are >=10 mm; lymph nodes must have a short axis of >=15 mm to be considered target lesions . 2. Time Point Response Derivation At each evaluation, an overall response status is d...
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