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: 2025-12-25 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:12 AM
NCT ID: NCT01903005
Term: Heroin toxicity
Organ System: Injury, poisoning and procedural complications
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA 16.0.
Notes: Condition led to death; non-treatment-emergent; not related to study drug.
Study: NCT01903005
Study Brief: Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 665 View