Safety Population. The Safety Population will include all patients who received at least one dose of study drug. This population will be used to summarize the safety data. Patients will be analyzed according to their treatment received; if an error in issuing IP occurs and a patient receives a mix of treatments, they will be analyzed under the treatment arm with the most IP issued to the patient.
Appears in 1 contract
Sources: Investigator Agreement
Safety Population. The Safety Population will include This population consists of all patients who received were enrolled, and who had at least one dose of study drug. This population All safety analyses will be used to summarize the safety data. Patients will be analyzed according to their treatment received; if an error in issuing IP occurs and a patient receives a mix of treatments, they will be analyzed under the treatment arm with the most IP issued to the patientperformed on this population.
Appears in 1 contract
Sources: Material Transfer and License Option Agreement (MIGENIX Inc.)