Participants receive PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.

Participants receive PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg.

Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.

Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Total of all reporting groups

Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

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.

All enrolled participants

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.

All enrolled participants

Participants received PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Participants received PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Participants received PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Participants received PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.

Participants received PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also received 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen was not to exceed 3000 mg.