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 @ 4:43 AM
Ignite Modification Date: 2025-12-26 @ 3:44 AM
NCT ID: NCT04989218
Term: hospitalization
Organ System: Gastrointestinal disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: None
Notes: Subject with intrahepatic cholangiocarcinoma was admitted to hospital on 7/3/2023 with Grade 3 vomiting and hypomagnesemia. Started C1D1 on 4/28/23. Last dose drug on 6/9/23. Treated, discharged 7/9/23. Possibly related-Gemcitabine or Cisplatin.
Study: NCT04989218
Study Brief: Durvalumab and Tremelimumab With Platinum-based Chemotherapy in Intrahepatic Cholangiocarcinoma (ICC)
Serious Event Stats (If Any):

Serious Event Stats

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