Serious Event

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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 @ 5:29 PM
Ignite Modification Date: 2025-12-25 @ 3:03 PM
NCT ID: NCT01243268
Term: Cardiac failure congestive
Organ System: Cardiac disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA 19.0
Notes: None
Study: NCT01243268
Study Brief: A Regulatory Requirement Post-Marketing Surveillance Study to Monitor the Safety and Efficacy of Twynsta (Telmisartan + Amlodipine SPC, q.d.) in Korean Hypertensive Patients Requiring Combination Therapy
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 1 610 View