Created at Source Raw Value Validated value
Jan. 13, 2022, 11 p.m. oms

Response to treatment: (favorable/unfavorable). Measurement time: month 1; month 3 and month 6.For cardiovascular sequelae will be considered favorable response to treatment when the patient progresses from greater to less cardiovascular damage according to the evaluative exercise stress test and according to the NYHA (New York Heart Association) classification. Unfavorable response: when; based on the above criteria; the patient progresses the greater the cardiovascular damage or the condition is not modified compared to the initial one). For renal sequelae will be considered favorable response to treatment in those patients who achieve clinical improvement given by moving from a category from higher to lower kidney damage; according to the KDIGO functional classification of kidney damage. Unfavorable response: Patients who do not change category or go to a higher category at the end of the study). For respiratory sequelae will be consider favorable response when the forced vital capacity (FVC) does not vary or is reduced by less than 10% in patients with pulmonary fibrosis and does not vary or is reduced by less than 5% in patients with another respiratory disorder with respect to the initial measurement. Unfavorable response: when the FVC is reduced more than 10% with respect to the initial measurement in patients with pulmonary fibrosis; and more than 5% in patients with another respiratory disorder). For mixed sequelae will be considered favorable response when: cuando alcanza el criterio de favorable para ambos tipos de secuelas. Respuesta desfavorable: cuando el criterio es desfavorable para al menos un secuela.Measurement time: At 1 month; month 3 and month 6.

Response to treatment: (favorable/unfavorable). Measurement time: month 1; month 3 and month 6.For cardiovascular sequelae will be considered favorable response to treatment when the patient progresses from greater to less cardiovascular damage according to the evaluative exercise stress test and according to the NYHA (New York Heart Association) classification. Unfavorable response: when; based on the above criteria; the patient progresses the greater the cardiovascular damage or the condition is not modified compared to the initial one). For renal sequelae will be considered favorable response to treatment in those patients who achieve clinical improvement given by moving from a category from higher to lower kidney damage; according to the KDIGO functional classification of kidney damage. Unfavorable response: Patients who do not change category or go to a higher category at the end of the study). For respiratory sequelae will be consider favorable response when the forced vital capacity (FVC) does not vary or is reduced by less than 10% in patients with pulmonary fibrosis and does not vary or is reduced by less than 5% in patients with another respiratory disorder with respect to the initial measurement. Unfavorable response: when the FVC is reduced more than 10% with respect to the initial measurement in patients with pulmonary fibrosis; and more than 5% in patients with another respiratory disorder). For mixed sequelae will be considered favorable response when: cuando alcanza el criterio de favorable para ambos tipos de secuelas. Respuesta desfavorable: cuando el criterio es desfavorable para al menos un secuela.Measurement time: At 1 month; month 3 and month 6.

June 26, 2021, 5:30 a.m. oms

Serious adverse events attributable to ior®EPOCIM (Adverse events classified as serious as serious (serious); causing the death of the patient; threatening his life; resulting in his hospitalization or prolongation of an existing hospitalization; causing significant disability / disability or persistent; birth defects or congenital anomalies or constitute an important medical event; which according to medical criteria; could risk the health of the patient or could require medical or surgical intervention to prevent the occurrence of any of the previously listed outcomes) ; and with a causal relationship definitive; very probable; probable; possible ). Measurement time: 6 months.

Serious adverse events attributable to ior®EPOCIM (Adverse events classified as serious as serious (serious); causing the death of the patient; threatening his life; resulting in his hospitalization or prolongation of an existing hospitalization; causing significant disability / disability or persistent; birth defects or congenital anomalies or constitute an important medical event; which according to medical criteria; could risk the health of the patient or could require medical or surgical intervention to prevent the occurrence of any of the previously listed outcomes) ; and with a causal relationship definitive; very probable; probable; possible ). Measurement time: 6 months.