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 @ 3:08 AM
Ignite Modification Date: 2025-12-26 @ 1:47 AM
NCT ID: NCT01097005
Term: Disorientation
Organ System: Psychiatric disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA 17.0
Notes: Causal relationship with the study drug was rated as "possible" by the investigator.
Study: NCT01097005
Study Brief: Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 441 View