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 @ 11:37 PM
Ignite Modification Date: 2025-12-25 @ 9:27 PM
NCT ID: NCT03763656
Term: Vaso-occlusive Crisis (VOC)
Organ System: Blood and lymphatic system disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA (23.1)
Notes: Grade 3, requiring hospitalisation \>7days (n=2 participants)
Study: NCT03763656
Study Brief: Pharmacokinetics of Oral Hydroxyurea Solution
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 2 2 32 View