Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)

An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Best Objective Response data were based on World Health Organization (WHO) criteria and included four categories. Complete Response (CR) was the disappearance of all clinically detectable malignant disease. Partial Response (PR) was a decrease of ≥50% of the sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; and a decrease of ≥50% in sum of largest diameters of all unidimensionally measure lesions. Stable Disease (SD) was a <50% decrease or <25% increase in sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; or a <50% decrease or <25% increase in sum of diameters of all unidimensionally measurable lesions. In addition, no new lesions appeared. Progressive Disease (PD) was a ≥25% increase in size of at least one bidimensionally or unidimensionally measurable lesion or appearance of new lesion. Occurrence of pleural effusion or ascites was also considered PD if substantiated by positive cytology.