Follow-up of adverse events
fatigue, fever, throat, SAEs, nasal congestion, headache, nasal dryness, Cancer
ADVERSE EVENT, ALLERGIC REACTION, ADVERSE EVENTS, ADVERSE EVENT, EVENTS, AUTOIMMUNE REACTION, CANCER
Participants self-monitored for safety post-administration and spontaneously reported adverse events (e.g. runny nose, sneezing, nasal congestion, nasal dryness, fever, headache, and fatigue) post-administration to study follow-up personnel. Predefined symptoms (solicited events) and other unspecified symptoms (unsolicited events) reported by the participants during the study period were recorded and verified at regular visits by the study investigators. Any SAEs and AESIs (e.g. allergic reaction, autoimmune reaction, and nasal and throat AEs of Grade two and above) were reported up to 30 days since enrollment. Adverse events were graded according to the US National Cancer Institute’s Common Terminology Criteria for Adverse Events (version 5.0) [