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 @ 12:24 PM
Ignite Modification Date: 2025-12-25 @ 12:04 PM
NCT ID: NCT03833661
Term: Keratoacanthoma
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Assessment Type: NON_SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA version 23.1
Notes: None
Study: NCT03833661
Study Brief: M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 None 1 159 View