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 @ 2:50 AM
Ignite Modification Date: 2025-12-26 @ 1:32 AM
NCT ID: NCT01715233
Description: Only Grades 3 and 4 adverse events were collected for all patients.
Frequency Threshold: 0
Time Frame: AEs assessed during each study visit for up to 1 year; All-Cause Mortality was assessed for up to 2 years.
Study: NCT01715233
Study Brief: Phase II Study Using CHFR Methylation Status in Patients With Metastatic Esophageal, Gastroesophageal, Gastric Cancer.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metastatic Esophageal, Gastroesophageal & Gastric Cancer Patients received modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer. Docetaxel: Modified Docetaxel 40mg/m2 on Day 1 Leucovorin: Leucovorin 400mg/m2 on Day 1 Fluorouracil: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 Cisplatin: Cisplatin (or Carboplatin) 40mg/m2 on Day 3 19 None 3 21 18 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 4.03 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE 4.03 View
Leukocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hospitalization due to leg pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.03 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Leukocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Fainting NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.03 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE 4.03 View
GI Bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE 4.03 View
Hypomagnesemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Hypotensive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE 4.03 View
Increased INR NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE 4.03 View
Hypophosphatemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Lymphopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE 4.03 View