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 @ 12:20 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT03344861
Term: Gastrointestinal haemorrhage
Organ System: Gastrointestinal disorders
Assessment Type: SYSTEMATIC_ASSESSMENT
Source Vocabulary: MedDRA (17.1)
Notes: On Study Day 4, subject received 2 doses of Toradol and on that same day complained of stomachache. On Study Days 4 \& 5 subject had diarrhea. On Study Day 5 subject was diagnosed with moderate gastrointestinal bleed (CTCAE Grade 2).
Study: NCT03344861
Study Brief: Safety of PDT-Photofrin® Prior to Lung Surgery
Serious Event Stats (If Any):

Serious Event Stats

Group ID # Events # Affected # At Risk View
EG000 1 1 10 View