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 @ 3:08 AM

Ignite Modification Date: 2025-12-26 @ 1:47 AM

NCT ID: NCT00466505

Description: None

Frequency Threshold: 5

Time Frame: None

Study: NCT00466505

Study Brief: Cetuximab & Celecoxib for Metastatic Colorectal Cancer or Colorectal Cancer That Cannot Be Removed by Surgery

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Therapeutic Intervention	None	None	None	2	17	17	17	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Hemorrhage, bladder	None	Renal and urinary disorders	None	View
neurology, brain mets	None	Nervous system disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

hypoalbuminemia	None	Metabolism and nutrition disorders	None	View
alkaline phosphatase	None	Investigations	None	View
allergic reaction	None	General disorders	None	View
ALT, SGPT	None	Metabolism and nutrition disorders	None	View
anorexia	None	Psychiatric disorders	None	View
AST, SGOT	None	Blood and lymphatic system disorders	None	View
hyperbilirubinemia	None	Metabolism and nutrition disorders	None	View
hypocalcemia	None	Metabolism and nutrition disorders	None	View
edema	None	General disorders	None	View
cataract	None	Eye disorders	None	View
constipation	None	Gastrointestinal disorders	None	View
cough	None	Respiratory, thoracic and mediastinal disorders	None	View
dermatologic general	None	Skin and subcutaneous tissue disorders	None	View
diarrhea	None	Gastrointestinal disorders	None	View
dizziness	None	Nervous system disorders	None	View
dyspnea	None	Respiratory, thoracic and mediastinal disorders	None	View
dyspepsi	None	Gastrointestinal disorders	None	View
hemoglobin	None	Investigations	None	View
hemorrhage, rectum	None	Gastrointestinal disorders	None	View
hemorrhage, bladder	None	Renal and urinary disorders	None	View
hemorrhage, pulmonary	None	Respiratory, thoracic and mediastinal disorders	None	View
hemorrhoids	None	Gastrointestinal disorders	None	View
hot flashes	None	Vascular disorders	None	View
hypotension	None	Vascular disorders	None	View
hiccoughs	None	Respiratory, thoracic and mediastinal disorders	None	View
anal incontinence	None	Gastrointestinal disorders	None	View
infection	None	Infections and infestations	None	View
infection with normal ANC	None	Infections and infestations	None	View
insomnia	None	Psychiatric disorders	None	View
leukocytes	None	Blood and lymphatic system disorders	None	View
hypomagnesiumia	None	Metabolism and nutrition disorders	None	View
hypercholesterolemia	None	Metabolism and nutrition disorders	None	View
agitation	None	Psychiatric disorders	None	View
depression	None	Psychiatric disorders	None	View
muscle weakness	None	Musculoskeletal and connective tissue disorders	None	View
reflux	None	Gastrointestinal disorders	None	View
hyperglycemia	None	Metabolism and nutrition disorders	None	View
nail changes	None	Skin and subcutaneous tissue disorders	None	View
restless leg	None	Nervous system disorders	None	View
balanitis	None	Skin and subcutaneous tissue disorders	None	View
peripheral neuropathy	None	Nervous system disorders	None	View
eye irritation	None	Eye disorders	None	View
pain, abdominal	None	Gastrointestinal disorders	None	View
pain, back	None	Musculoskeletal and connective tissue disorders	None	View
pain, extremity	None	Musculoskeletal and connective tissue disorders	None	View
pain, head	None	Nervous system disorders	None	View
pain, muscle	None	Musculoskeletal and connective tissue disorders	None	View
pain, rib cage	None	Musculoskeletal and connective tissue disorders	None	View
pain, rectum	None	Gastrointestinal disorders	None	View
platelets	None	Investigations	None	View
pruritus, itching	None	Skin and subcutaneous tissue disorders	None	View
rash, desquamation	None	Skin and subcutaneous tissue disorders	None	View
hand, foot rash	None	Skin and subcutaneous tissue disorders	None	View
hypokalemia	None	Metabolism and nutrition disorders	None	View
urinary frequency	None	Renal and urinary disorders	None	View
urinary retention	None	Renal and urinary disorders	None	View
hyponatremia	None	Metabolism and nutrition disorders	None	View
diaphoresis, sweating	None	Vascular disorders	None	View
tremor	None	Nervous system disorders	None	View
vomiting	None	Gastrointestinal disorders	None	View
vaginal discharge	None	Reproductive system and breast disorders	None	View
hoarseness	None	Respiratory, thoracic and mediastinal disorders	None	View
blurred vision	None	Eye disorders	None	View
flatulence	None	Gastrointestinal disorders	None	View
fever	None	General disorders	None	View
fatigue	None	General disorders	None	View