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 @ 5:02 AM
Ignite Modification Date: 2025-12-26 @ 4:03 AM
NCT ID: NCT00471718
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00471718
Study Brief: ABT-751 in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone 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
Phase I/II: ABT-751 Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle None None 7 27 27 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pain, tumor None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
hemoglobin None Blood and lymphatic system disorders None View
mood alteration None Psychiatric disorders None View
dehydration None Metabolism and nutrition disorders None View
nausea None Gastrointestinal disorders None View
vomiting None Gastrointestinal disorders None View
hyperglycemia None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
confusion None Psychiatric disorders None View
neuropathy cranial None Nervous system disorders None View
neuropathy motor weakness None Nervous system disorders None View
speech impairment None Nervous system disorders None View
extrapyramidal None Nervous system disorders None View
fever None General disorders None View
Infection with normal ANC None Infections and infestations None View
memory impairment None Psychiatric disorders None View
Fecal incontinence None Gastrointestinal disorders None View
back pain None Musculoskeletal and connective tissue disorders None View
extremity pain None Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation NON_SYSTEMATIC_ASSESSMENT General disorders None View
neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
gastrointestinal disorders NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
anorexia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
alkaline phosphatase increase SYSTEMATIC_ASSESSMENT Investigations None View
depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
fever SYSTEMATIC_ASSESSMENT General disorders None View
infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
weight loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
sweats NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
hyperuricemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
xerostomia None Gastrointestinal disorders None View
elevated transaminases None Metabolism and nutrition disorders None View
hematuria None Renal and urinary disorders None View
urine retention None Renal and urinary disorders None View
renal failure None Renal and urinary disorders None View