Non-inferiority
Regulatory scientific advice on non-inferiority drug trials.
... a non-inferiority design has gained popularity in recent ...However, non-inferiority trials present some methodological challenges, especially in determining the non-inferiority ...
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A randomized, non-inferiority study comparing efficacy and safety of a single dose of pegfilgrastim versus daily filgrastim in pediatric patients after autologous peripheral blood stem cell transplant.
... Results: Sixty-one patients, with a median age of 11.5 years, were recruited: 29 in the filgrastim arm and 32 in the pegfilgrastim arm. Twenty percent were affected by lymphoma/leukaemia and eighty percent by solid ...
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Randomised controlled double-blind non-inferiority trial of two antivenoms for saw-scaled or carpet viper (Echis ocellatus) envenoming in Nigeria.
... controlled, non-inferiority trial, ‘‘EchiTAb Plus-ICP’’ (ET-Plus) equine antivenom made by Instituto Clodomiro Picado was compared to ‘‘EchiTAb G’’ (ET-G) ovine antivenom made by MicroPharm, which is the ...
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Immunogenicity of fractional doses of tetravalent a/c/y/w135 meningococcal polysaccharide vaccine: results from a randomized non-inferiority controlled trial in Uganda.
... randomized, non-inferiority trial in 750 healthy volunteers 2–19 years old in Mbarara, Uganda, to compare the immune response of the full dose of the vaccine versus fractional doses (1/5 or ...95%. ...
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Pyronaridine-artesunate versus chloroquine in patients with acute Plasmodium vivax malaria: a randomized, double-blind, non-inferiority trial.
... was non-inferior to that of chloroquine (100%). Non- inferiority of pyronaridine-artesunate to chloroquine was main- tained throughout the ...
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Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial
... the non- inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as active ...
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Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial.
... Women’s home-assessment had a higher abortion success rate (95%) compared with women in the clinic follow-up group (93%), and thus proves efficacy of simplified medical abortion also in [r] ...
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Braz. j. . vol.82 número5
... Methods: Phase III, randomized, non-inferiority, national, open study comparing mometasone furoate in two presentations (control drug and investigational drug). The primary endpoint was the percentage of ...
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Arq. Bras. Cardiol. vol.95 número4
... Moreover, it specifies that, in case of non-new biological products (i.e., biosimilars), the individual requesting the registration can alternatively present non-inferiority clinical trials to ...
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Clinics vol.71 número10
... Notably, the incidence of grade 4 neutropenia in both groups was lower than that used in the sample size calcula- tion, most likely because blood counts were analyzed every two days. Consequently, an exploratory analysis ...
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... erte Non-Inferiority-Studie, in welcher das oral verfügbare Rivaroxaban (initial durch 3 Wochen 2× täglich 15 mg und in weiterer Folge einmal täglich 20 mg) mit einer Standardthera- pie (subkutanes ...
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J. vasc. bras. vol.9 número3 en a09v9n3
... protection against suspicion of conscious or unconscious exclusion of undesired data. It is also known that the analysis according to ITT provides a more conservative result, reducing the differences between treatments ...
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Eficácia e tolerabilidade da homeopatia e da fluoxetina no tratamento da depressão
... the non-inferiority and tolerability of individualized homeopathic medicines (Q-potencies) in acute depression, using fluoxetine as active ...a non-inferiorit y test with margin of ...treatment. ...
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Arq. NeuroPsiquiatr. vol.72 número10
... The two-arm Clinical Decisions/Diagnostic Workshop (CD/DW) approach to undergraduate medical education has been successfully used in Brazil. Objective: Present the CD/DW approach to the teaching of stroke, with the ...
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Sao Paulo Med. J. vol.129 número3
... while non-inferiority study designs may be considered when appropriately ...that non- inferiority may contradict the principle of ...for non-inferiority study designs than the ...
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J. Bras. Patol. Med. Lab. vol.49 número1
... When comparing the results from imprints and non-clariied smears for silver staining with those from culture, there was low correlation between the values. Compatible structures with leptospires were observed by ...
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DANO OCUPACIONAL NA UNIDADE DE TERAPIA INTENSIVA NEONATAL: A PERCEPÇÃO DA ENFERMEIRA
... e non è un caso, spiega Bataille, che anche quel primo “balbettio” umano, l’uomo di Neanderthal, conoscesse la morte e procedesse alle prime ...animali non esiste la percezione della morte di un proprio ...
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Role of non-coding RNAs in non-aging-related neurological disorders
... Neurodegenerative and neuromuscular disorders. Neurodegenerative disorders are associated with a wide range of genetic mutations and epigenetic and environ- mental factors. Among genetic mutations, trinucleotide repeat ...
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Non-cooperative iris recognition
... The greatest drawback when intending to perform iris recognition in non-controlled conditions is clearly the associated noise. Figure 3.5 containing images from UBIRIS.v2, a non-cooperative iris database ...
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Non commercial use only
... Although the anatomical structures are segmented, the multilayer concept was not fully implemented in the input model since there are no corresponding surface vector components fo[r] ...
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