Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:15 AM
Ignite Modification Date: 2025-12-26 @ 3:15 AM
NCT ID: NCT03736720
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were followed for up to 3 years following treatment initiation, with a median time of 182 days.
Study: NCT03736720
Study Brief: Liposomal Irinotecan, Fluorouracil and Leucovorin in Treating Patients With Refractory Advanced High Grade Neuroendocrine Cancer of Gastrointestinal, Unknown, or Pancreatic Origin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) Patients receive liposomal irinotecan IV over 90 minutes, leucovorin IV over 30 minutes, and fluorouracil IV over 46 hours on days 1 and 15. Courses repeat every 28 days for in the absence of disease progression or unacceptable toxicity. Fluorouracil: Given IV Leucovorin: Given IV Liposomal Irinotecan: Given IV Quality-of-Life Assessment: Correlative studies 1 None 6 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Superior vena cava syndrome SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
CD4 lymphocytes decreased SYSTEMATIC_ASSESSMENT Investigations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Metabolism and nutrition disorders **Any AE - Maximum Grade Seen Hypokalemia Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Superior vena cava syndrome SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View