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 @ 1:18 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT01047293
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01047293
Study Brief: RAD001, FOLFOX and Bevacizumab in Treatment of Colorectal Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Patients All participants enrolled. None None 18 47 47 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
anemia None Blood and lymphatic system disorders None View
bowel perforation None Gastrointestinal disorders None View
c-diff infection None Infections and infestations None View
cholecystitis None Gastrointestinal disorders None View
confusion None Nervous system disorders None View
dehydration None Metabolism and nutrition disorders None View
diarrhea None Gastrointestinal disorders None View
Deep Vein Thrombosis None Blood and lymphatic system disorders None View
epistaxis None Respiratory, thoracic and mediastinal disorders None View
failure to thrive None Investigations None View
febrile neutropenia None Blood and lymphatic system disorders None View
fever None General disorders None View
fistula - small bowel None Gastrointestinal disorders None View
hypoxia None Respiratory, thoracic and mediastinal disorders None View
Infection - hepatic None Infections and infestations None View
Infection - pseudomonas None Infections and infestations None View
infection - urinary tract None Infections and infestations None View
Infections and other systemic inflammatory syndrome None Infections and infestations None View
left ventricular systolic dysfunction None Cardiac disorders None View
lipase increased None Metabolism and nutrition disorders None View
mucositis None Gastrointestinal disorders None View
muscle weakness None Musculoskeletal and connective tissue disorders None View
nausea None Gastrointestinal disorders None View
neutropenia None Blood and lymphatic system disorders None View
pain - abdominal None Gastrointestinal disorders None View
pain - chest None General disorders None View
pain - rectal/anal None Gastrointestinal disorders None View
pancreatitis None Gastrointestinal disorders None View
pericarditis None Cardiac disorders None View
pneumonia - aspiration None Respiratory, thoracic and mediastinal disorders None View
pulmonary emboli None Vascular disorders None View
Renal calculi None Renal and urinary disorders None View
thrush None Infections and infestations None View
vasospasms None Vascular disorders None View
vomiting None Gastrointestinal disorders None View
weight loss None Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
alkaline phosphatase increased None Metabolism and nutrition disorders None View
allergic reaction - anaphylactic None Immune system disorders None View
alopecia None Skin and subcutaneous tissue disorders None View
Alanine aminotransferase increased None Investigations None View
anorexia None Gastrointestinal disorders None View
arthralgia None Musculoskeletal and connective tissue disorders None View
bruising None Injury, poisoning and procedural complications None View
c-diff infection None Infections and infestations None View
congestion - sinus None Respiratory, thoracic and mediastinal disorders None View
constipation None Gastrointestinal disorders None View
creatinine increased None Investigations None View
dehydration None Metabolism and nutrition disorders None View
depression None Psychiatric disorders None View
diarrhea None Gastrointestinal disorders None View
dry skin None Skin and subcutaneous tissue disorders None View
vomiting None Gastrointestinal disorders None View
weight loss None Investigations None View
deep vein thrombosis None Vascular disorders None View
dysgeusia None Gastrointestinal disorders None View
dysphagia None Gastrointestinal disorders None View
dyspnea None Respiratory, thoracic and mediastinal disorders None View
dysuria None Renal and urinary disorders None View
edemia - penile/groin None General disorders None View
epistaxis None Respiratory, thoracic and mediastinal disorders None View
fatigue None General disorders None View
fever None General disorders None View
flatulence None Gastrointestinal disorders None View
Erythroderma None Skin and subcutaneous tissue disorders None View
headache None Nervous system disorders None View
hematuria None Renal and urinary disorders None View
hemorrhage - rectal None Vascular disorders None View
hemorrhoids None Gastrointestinal disorders None View
hypercholesterolemia None Investigations None View
hyperglycemia None Metabolism and nutrition disorders None View
hypertension None Vascular disorders None View
hypertriglyceridemia None Metabolism and nutrition disorders None View
hypocalcemia None Metabolism and nutrition disorders None View
hypokalemia None Metabolism and nutrition disorders None View
hyponatremia None Metabolism and nutrition disorders None View
hypophosphatemia None Metabolism and nutrition disorders None View
hypoxia None Respiratory, thoracic and mediastinal disorders None View
infection - gums None Infections and infestations None View
infection - tooth None Infections and infestations None View
infection - urine/yeast None Infections and infestations None View
infection - vaginial None Infections and infestations None View
insomnia None Psychiatric disorders None View
leukopenia None Blood and lymphatic system disorders None View
lymphopenia None Blood and lymphatic system disorders None View
malaise None General disorders None View
mucositis None Gastrointestinal disorders None View
myalgia None Musculoskeletal and connective tissue disorders None View
nail changes None General disorders None View
nausea None Gastrointestinal disorders None View
neuropathy None Nervous system disorders None View
neutropenia None Blood and lymphatic system disorders None View
night sweats None General disorders None View
pain - unspecified None Gastrointestinal disorders None View
pain - abdominal None General disorders None View
pain - back None General disorders None View
pain - chest None General disorders None View
pain - extremity None General disorders None View
pain - rectal/anal None Gastrointestinal disorders None View
pain - shoulders None General disorders None View
pleural effusion None Respiratory, thoracic and mediastinal disorders None View
pneumonitis None Respiratory, thoracic and mediastinal disorders None View
post nasal drip None Respiratory, thoracic and mediastinal disorders None View
proteinuria None Renal and urinary disorders None View
pulmonary emboli None Respiratory, thoracic and mediastinal disorders None View
rash None Skin and subcutaneous tissue disorders None View
rash - acneiform None Skin and subcutaneous tissue disorders None View
rash - pruritic None Skin and subcutaneous tissue disorders None View
sore throat None Respiratory, thoracic and mediastinal disorders None View
tachycardia - sinus None Cardiac disorders None View
thrombocytopenia None Blood and lymphatic system disorders None View
thrush None Infections and infestations None View
toothache None General disorders None View
voice changes None General disorders None View
anemia None Blood and lymphatic system disorders None View
anxiety None Psychiatric disorders None View
Aspartate aminotransferase increased None Investigations None View
ataxia None Nervous system disorders None View
confusion None Psychiatric disorders None View
cough None Respiratory, thoracic and mediastinal disorders None View
dizziness None Nervous system disorders None View
dry mouth None Gastrointestinal disorders None View
body aches SYSTEMATIC_ASSESSMENT General disorders None View