Adverse events
teratogenesis, death, disability, CRF
TERATOGENESIS, SEQUELA, ADVERSE EVENTS, ADVERSE EVENT, CRF, EVENTS, EVENTS
Adverse events are any unfavourable or unintended events that affect patients on study, regardless of the relevance to the treatment. Any adverse events will be recorded in detail on the CRF regarding its occurrence time, duration, relevance to the treatment, stopping or continuing of the treatment, etc. Events are defined as serious adverse events if leading to death, prolongation of hospitalization, permanent or severe disability, teratogenesis or carcinagensis, and significant clinical sequela [