Toxicity reporting
Local trial centers conducted mandatory documentation of toxicities for
each treatment element based on the National Cancer Institute’s Common
Terminology Criteria for Adverse Events (CTCAE) version 4.0, modified by
the German Society of Pediatric Oncology and Hematology on a
patient-specific therapy flowsheet. In addition, treatment-related
toxicities were documented in medical records. Severe adverse events
(SAE) were reported instantaneously. Treatment-related toxicities were
assigned to a specific treatment element, if they occurred during the
application of chemotherapy or before the next treatment element had
started.
As an additional surrogate marker for toxicity related to AEP treatment
we calculated the duration from the start of AEP until the beginning of
the subsequent therapy element.