Safety outcomes at Stage I
syncope, back pain, pain, infection, vasovagal reaction, depressed, backpain
ADVERSE EVENTS, ADVERSE EVENT, EVENT, INFECTION, OSTEOMYELITIS, VASOVAGAL REACTION, EVENTS, SEQUELAE
During leukapheresis procedures to harvest cells for DC generation, which were conducted before randomisation, there were six grade 3 adverse events (AE) reported: infection (1 event); backpain (1); syncope (2); depressed level of consciousness (1) and vasovagal reaction (1). One of the patients, who experienced three of these events, did not complete leukapheresis and withdrew before randomisation. The patient had osteomyelitis, back pain (managed with pain medication) and depressed level of consciousness. Once the SAE sequelae had resolved, the patient re-entered screening and ultimately completed all cycles of treatment without any further AEs. Adverse events experienced in Stage I of the treatment schedule are presented in Supplementary Table 4. No patients experienced a grade 3 or higher AE over the first two cycles of vaccination after randomisation in Stage I of the study.