Serious Event

Serious Event

Serious Adverse Events (SAEs) are adverse events that result in death, are life-threatening, require or prolong hospitalization, cause persistent or significant disability/incapacity, or are congenital anomalies/birth defects. Each serious event is categorized by term, organ system, assessment type, and source vocabulary to provide standardized reporting across clinical trials.

Serious Event path is as follows:

Study -> Results Section -> Adverse Events Module -> Serious Event

Study -> Results Section -> Adverse Events Module -> Serious Event -> Serious Event Stats

Serious Event


Ignite Creation Date: 2025-12-24 @ 2:47 PM
Ignite Modification Date: 2025-12-25 @ 1:15 PM
NCT ID: NCT02600559
Term: Influenza
Organ System: Infections and infestations
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA (18.1)
Notes: One of 4 adverse events that caused the subject to be hospitalized (also pneumonia, rhinovirus infection, and streptococcal infection); not related to study drug.
Study: NCT02600559
Study Brief: Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 501 1 501 View