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: 2025-12-24 @ 6:44 PM

Ignite Modification Date: 2025-12-25 @ 4:15 PM

NCT ID: NCT00522457

Description: None

Frequency Threshold: 5

Time Frame: None

Study: NCT00522457

Study Brief: Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy

Event Groups(If Any):

Event Groups

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

Ertumaxomab	None	None	None	11	19	19	19	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

hypotension	None	Vascular disorders	None	View
hemoptysis	None	Vascular disorders	None	View
medical observation	None	Investigations	None	View
abscess intestinal	None	Gastrointestinal disorders	None	View
nausea	None	Gastrointestinal disorders	None	View
bile duct obstruction	None	Hepatobiliary disorders	None	View
pyrexia	None	General disorders	None	View
infusion related reaction	None	General disorders	None	View
asthenia	None	General disorders	None	View
liver abscess	None	Hepatobiliary disorders	None	View
clostridial infection	None	Infections and infestations	None	View
urinary tract infection	None	Infections and infestations	None	View
malignant neoplasm progression	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
hydronephrosis	None	Renal and urinary disorders	None	View
renal failure	None	Renal and urinary disorders	None	View
ureteric obstruction	None	Renal and urinary disorders	None	View
pleural effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
respiratory acidosis	None	Respiratory, thoracic and mediastinal disorders	None	View
supraventricular tachycardia	None	Cardiac disorders	None	View
dehydration	None	Metabolism and nutrition disorders	None	View
pain in extremity	None	Musculoskeletal and connective tissue disorders	None	View
confusional state	None	Nervous system disorders	None	View
somnolence	None	Psychiatric disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

chills	None	General disorders	None	View
pyrexia	None	General disorders	None	View
fatigue	None	General disorders	None	View
pain	None	General disorders	None	View
chest pain	None	General disorders	None	View
flank pain	None	General disorders	None	View
flushing	None	General disorders	None	View
infusion related reaction	None	General disorders	None	View
asthenia	None	General disorders	None	View
lethargy	None	General disorders	None	View
nausea	None	Gastrointestinal disorders	None	View
vomiting	None	Gastrointestinal disorders	None	View
abdominal pain	None	Gastrointestinal disorders	None	View
constipation	None	Gastrointestinal disorders	None	View
diarrhoea	None	Gastrointestinal disorders	None	View
abdominal discomfort	None	Gastrointestinal disorders	None	View
abdominal distension	None	Gastrointestinal disorders	None	View
abscess intestinal	None	Gastrointestinal disorders	None	View
oral pain	None	Gastrointestinal disorders	None	View
headaches	None	Nervous system disorders	None	View
dizziness	None	Nervous system disorders	None	View
amnesia	None	Nervous system disorders	None	View
confusional state	None	Nervous system disorders	None	View
dysgeusia	None	Nervous system disorders	None	View
neuropathy	None	Nervous system disorders	None	View
peripheral sensory neuropathy	None	Nervous system disorders	None	View
photopsia	None	Nervous system disorders	None	View
hypotension	None	Vascular disorders	None	View
hpertension	None	Vascular disorders	None	View
hemoptysis	None	Vascular disorders	None	View
lymphoedema	None	Vascular disorders	None	View
aspartate aminotransferase increased	None	Investigations	None	View
alanine aminotransferase increased	None	Investigations	None	View
c-reactive protein increased	None	Investigations	None	View
medical observation	None	Investigations	None	View
blood alkaline phosphatase increased	None	Investigations	None	View
c-reactive protein	None	Investigations	None	View
electrocardiogram QT prolonged	None	Investigations	None	View
gamma-glutamyltransferase increased	None	Investigations	None	View
weight decreased	None	Investigations	None	View
back pain	None	Musculoskeletal and connective tissue disorders	None	View
pain in extremity	None	Musculoskeletal and connective tissue disorders	None	View
arthralgia	None	Musculoskeletal and connective tissue disorders	None	View
myalgia	None	Musculoskeletal and connective tissue disorders	None	View
muscle spasms	None	Musculoskeletal and connective tissue disorders	None	View
musculoskeletal stiffness	None	Musculoskeletal and connective tissue disorders	None	View
pain in jaw	None	Musculoskeletal and connective tissue disorders	None	View
dehydration	None	Metabolism and nutrition disorders	None	View
hypermagnesemia	None	Metabolism and nutrition disorders	None	View
hypokalaemia	None	Metabolism and nutrition disorders	None	View
cough	None	Respiratory, thoracic and mediastinal disorders	None	View
wheezing	None	Respiratory, thoracic and mediastinal disorders	None	View
dyspnoea	None	Respiratory, thoracic and mediastinal disorders	None	View
dyspnoea exertional	None	Respiratory, thoracic and mediastinal disorders	None	View
pleural effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
respiratory acidosis	None	Respiratory, thoracic and mediastinal disorders	None	View
lymphopenia	None	Blood and lymphatic system disorders	None	View
anaemia	None	Blood and lymphatic system disorders	None	View
leukopenia	None	Blood and lymphatic system disorders	None	View
neutropenia	None	Blood and lymphatic system disorders	None	View
tachycardia	None	Cardiac disorders	None	View
sinus tachycardia	None	Cardiac disorders	None	View
supraventricular tachycardia	None	Cardiac disorders	None	View
oral herpes	None	Infections and infestations	None	View
clostridial infection	None	Infections and infestations	None	View
localised infection	None	Infections and infestations	None	View
upper respiratory tract infection	None	Infections and infestations	None	View
urinary tract infection	None	Infections and infestations	None	View
anxiety	None	Psychiatric disorders	None	View
insomnia	None	Psychiatric disorders	None	View
mood altered	None	Psychiatric disorders	None	View
somnolence	None	Psychiatric disorders	None	View
erythema	None	Skin and subcutaneous tissue disorders	None	View
hyperhidrosis	None	Skin and subcutaneous tissue disorders	None	View
ingrowing nail	None	Skin and subcutaneous tissue disorders	None	View
pallor	None	Skin and subcutaneous tissue disorders	None	View
rash	None	Skin and subcutaneous tissue disorders	None	View
malignant neoplasm progression	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
tumour pain	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
bile duct obstruction	None	Hepatobiliary disorders	None	View
jaundice	None	Hepatobiliary disorders	None	View
liver abscess	None	Hepatobiliary disorders	None	View
hydronephrosis	None	Renal and urinary disorders	None	View
renal failure	None	Renal and urinary disorders	None	View
ureteric obstruction	None	Renal and urinary disorders	None	View
cytokine release syndrome	None	Immune system disorders	None	View
oedema genital	None	Reproductive system and breast disorders	None	View
dysphonia	None	Respiratory, thoracic and mediastinal disorders	None	View
anorexia	None	Metabolism and nutrition disorders	None	View
hypocalcaemia	None	Metabolism and nutrition disorders	None	View
decreased appetite	None	Metabolism and nutrition disorders	None	View