Eliciting and Documenting Adverse Events. The investigator is responsible for ensuring that all AEs and SAEs are recorded in the eCRF and reported to SIGA by PPD. Adverse events and SAEs will be assessed from the first dose of study drug through the telephone call on Day 37 (+2 days). At every study visit or assessment, subjects will be asked a standard question to elicit any medically related changes in their well-being. They will also be asked if they have been hospitalized, had any accidents, used any new medications, or changed concomitant medication regimens (both prescription and over-the-counter medications). In addition to subject observations, AEs will be documented from any data collected on the AE page of the eCRF (eg, laboratory values, physical examination findings, and ECG changes) or other documents that are relevant to subject safety.
Eliciting and Documenting Adverse Events. Subjects will be asked a standard question to elicit any medically related changes in their well-being. They will also be asked if they have been hospitalized, had any accidents, used any new medications, or changed concomitant medication regimens (both prescription and over-the-counter medications). In addition to subject observations, AEs will be documented from any data collected on the AE page in the eCRF (eg, laboratory values, physical examination findings, and ECG changes) or other documents that are relevant to subject safety.
