Data collection
CRF
ADVERSE EVENTS, CRF
A clinical data management system provided by the Coordination Center for Clinical Trials (KKS) of the University of Heidelberg was used for data collection using an electronic CRF (eCRF) for remote data entry (RDE). All entries in the eCRF had to be verifiable by source documents. A detailed list of entries to the eCRF was provided in the Investigator Site File. Regardless, there had to be a minimum documentation, which provided information on study participation and included all medical information necessary for appropriate medical care outside of the clinical trial in the patient record. In addition, source documents had to mention that the subject had been included in an investigational study. Finally, there had to be no data that were inconsistent between eCRF and source documents. All protocol-required information collected during the trial had to be entered by the investigator or a designated representative into the eCRF. Patient data was documented pseudonymously. The investigator or a designated representative should complete the eCRF pages as soon as possible after the information was collected, preferably within two weeks after the study visit. Any pending entries had to be completed immediately after the final examination. Explanation had to be given for all missing data. The investigator was responsible for ensuring that all sections of the eCRF were completed correctly. Any errors had to be corrected in the eCRF and a reason for change had to be entered. The correctness of all entries in the eCRF had to be confirmed by dated electronic signature of the responsible investigator. The time points and frequency of electronic signatures were defined in the study-specific document “eCRF specification”.The primary data collection took place locally at the treating site. Data was collected from the data of informed consent until the discontinuation of study treatment. Following discontinuation of treatment, subjects were followed up 30 days after the last treatment or at initiation of another anti-cancer therapy (End of treatment visit). Patients were then contacted by their physician at day 100 for a safety follow-up and data regarding adverse events were recorded until day 100 after the final dose of study treatment. Thereafter, data regarding survival were collected every three months. Data was collected between December 12