Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Recombinant Interferon Alfa 2a · 1 trial · 3 indications
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; Life-threatening experience (immediate risk of dying); Persistent or significant disability or incapacity; and congenital anomaly.
| Arm | Type | Description |
|---|---|---|
| Interferon Alfa-2A in Cancer Participants | EXPERIMENTAL | Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study will continue to receive the same treatment in this study. Pegylated interferon alfa-2A will be administered subcutaneously once weekly and recombinant interferon alfa 2A will be administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurs first (up to approximately 3 years). |
| Name | Type | Description |
|---|---|---|
| Pegylated Interferon Alfa-2a | DRUG | Participants will maintain the same dose they were receiving in the parent protocol. |
| Recombinant Interferon Alfa 2a | DRUG | Participants will maintain the same dose they were receiving in the parent protocol. |
Inclusion Criteria: * Participants must have completed protocol NO15753, NO15764, NO16006 or NO16007 and responded to treatment at the end of the trial as defined in the parent protocol * CML participants must have a confirmed cytogenetic complete response within 2 months of entering the extension ...