Childhood Adenotonsillectomy Trial

7.4.2 Tracking Adverse Events and Serious Adverse Events for AT

All adverse events and SAEs will be documented and tracked using a composite data sheet (refer to Master Manual of Procedures). Specific information about adverse events relating to surgery will be supplemented by review of medical charts by the site project coordinator and PI as appropriate. Although this will require unblinding of the randomization status of these subjects, we anticipate these events will be unusual enough that the integrity of the study data will not be compromised.