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English to Spanish: Clinical trial General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English Grade 1-2 non-infective pyrexia was reported particularly in trial XXX (3-hour i.v. infusión every 2 weeks), where it was observed in 69%. It was usually associated with shivering and developed within 24 hours after the start of the infusion. For the 1-hour schedule, 5.2% and 2.6% of patients had grade 1 and 3 pyrexia, respectively.
To the cutoff date, 7.2% of the patients evaluable for safety reported hypersensitivity reactions after receiving XXX. Most of these events were mild or moderate, and grade 3-4 events were found in 3.0% of patients treated with the 3-hour infusion and 2.1% of patients treated with the 1-hour infusion schedule. Additionaly, 0.6% of patients with grade 4 anaphylactic shock were found with the 3-hour infusion schedule. Due to these Abs, all new trials with XXX require premedication with anti-H2 and anti-H1 antihistaminics and glucocorticoids.
Translation - Spanish Se registró fiebre no infecciosa grado 1-2 particularmente en la prueba APL-A-001b-98 (infusión intravenosa de 3 h cada 2 semanas) en la que 68 % de los pacientes mostraron este síntoma. La fiebre estuvo relacionada con temblores y se manifestó dentro de las 24 h luego de administrar la infusión. En el tratamiento de 1 h, el 5,2 % de los pacientes padecieron fiebre de grado 1 y el 2,6% fiebre de grado 3.
Hasta la fecha que se alcanzó el valor de corte, 7,2 % de los pacientes que se evaluaron por seguridad habían sufrido hipersensibilidad luego de recibir plitidepsina. La mayoría de estos eventos fueron leves o moderados. Se reportaron eventos de grado 3-4 en el 3.0 % de los pacientes a los que se le administró el tratamiento de 3h y en el 2,1 % de los pacientes a los que se le administró el tratamiento de 1h. Así también, el 0,6 % de los pacientes padeció anafilaxis grado 4. Por estos EA, todas las pruebas nuevas de plitidepsina deben ser precedidas con antihistamínicos H1 y H2 y glucocorticoides.
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Years of experience: 14. Registered at ProZ.com: Mar 2014.
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