Disease progression definition

Disease progression means the process of a disease becoming more severe or spreading from one area of a human body to another area of the human body.
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Disease progression using Defined as [ * ]. modified RECIST criteria Re-treatment Litx(TM)+chemo [ * ] Group Survival All patients will be monitored for survival from the time of randomization [ * ]. Data Safety Monitoring Board [ * ] (DSMB) Criteria of Evaluation [ * ] Statistical Methodology [ * ] 3 STUDY OBJECTIVES Assess the time to progression in patients [ * ]. Demonstrate the safety of Litx(TM) therapy. Assess the survival of patients [ * ].
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Examples of Disease progression in a sentence

  • Disease progression is an anticipated occurrence in oncology drug development and is not an AE unto itself.

  • Prior therapy must have included: ⎯ Anthracycline or bendamustine-containing chemotherapy, and ⎯ Anti-CD20 monoclonal antibody therapy, and ⎯ Ibrutinib or acalabrutinib 103) Relapsed or refractory disease, defined by the following: ⎯ Disease progression after last regimen, or ⎯ Refractory disease is defined failure to achieve a partial response (PR) or CR to the last regimen 104) At least 1 measurable lesion.

  • Disease progression at 6 months All patients that receive trial treatment will be included in the analysis to determine the percentage of patients progressing by RECIST 1.1 criteria at 6 months when maintained on a combination regimen of paricalcitol plus pembrolizumab versus pembrolizumab alone.

  • Disease progression from HIV to AIDS is tracked by CD4+ counts and other co-infections, such as tuberculosis.

  • Topo) chosen prior to randomization Disease progression will be evaluated by the Investigator using RECIST v 1.1 (Appendix B).

  • Events that meet the criteria for serious but are thought to be associated with the progression of the disease under study should be reported as SAEs. NOTE: Disease progression per se should not be reported as an SAE.

  • Disease progression will not be determined by CA19-9, however increases in CA19-9 may warrant the investigator to obtain radiographic assessments.

  • Disease progression and patient response will dictate dose adjustments.

Related to Disease progression

  • Disease means an alteration in the state of the body or of some of its organs, interrupting or disturbing the performance of the functions, and causing or threatening pain and weakness or physical or mental disorder and certified by a Medical Practitioner.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • Phase II Trial means a clinical trial of a Licensed Product, designated as a Phase II Trial and the principal purpose of which is to make a preliminary determination that such Licensed Product is safe and active in a patient population for its intended use and is designed to obtain sufficient information about such Licensed Product’s efficacy to permit the design of a Phase III Trial(s), and generally consistent with 21 CFR § 312.21(b). For purposes of this definition, Phase II trial shall specifically exclude expansion cohorts from Phase I Trial(s).