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

Response to treatment (It will measure through the variation of forced vital capacity (FVC) in the categories favorable or unfavorable. It will be considered Favorable response when 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 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). Measurement time: days 63 and 182.

Response to treatment (It will measure through the variation of forced vital capacity (FVC) in the categories favorable or unfavorable. It will be considered Favorable response when 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 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). Measurement time: days 63 and 182.

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

Grade 3; 4 or 5 toxicity attributable to the therapeutic vaccine CIMAvax-EGF® (Occurrence of adverse events (AE) with severity grade 3 (severe); 4 (serious that threat or incapacitating) or 5 (serious that produces death) with a Causality relationship attributable to the product (definitive; very probable; probable; possible)). Measurement time: 6 months.

Grade 3; 4 or 5 toxicity attributable to the therapeutic vaccine CIMAvax-EGF® (Occurrence of adverse events (AE) with severity grade 3 (severe); 4 (serious that threat or incapacitating) or 5 (serious that produces death) with a Causality relationship attributable to the product (definitive; very probable; probable; possible)). Measurement time: 6 months.