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 @ 5:03 AM
Ignite Modification Date: 2025-12-26 @ 4:05 AM
NCT ID: NCT00145418
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00145418
Study Brief: Oxaliplatin and Docetaxel as First-line Therapy for Advanced Non-small Cell Lung 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
Oxaliplatin + Docetaxel Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer None None 9 15 15 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Catheter infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
clostridium difficile colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
chest pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
DVT SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
dysguesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
thrombocytopenia SYSTEMATIC_ASSESSMENT Vascular disorders None View
neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View