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 @ 11:18 PM
Ignite Modification Date: 2025-12-25 @ 8:58 PM
NCT ID: NCT00717756
Description: None
Frequency Threshold: 5
Time Frame: From time of signing consent to approximately 30 days post last dose of drug, for a maximum of 4 years
Study: NCT00717756
Study Brief: Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lenalidomide lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle None None 18 40 40 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
edema gr 3, lethargy gr 2, HGB gr 2, hypotension gr 2 SYSTEMATIC_ASSESSMENT Investigations None View
vasovagal episode gr3 SYSTEMATIC_ASSESSMENT Investigations None View
ascites gr3, Liver dysfunction gr 3, fatigue gr 3, dehydration gr 3, vomiting gr 2, constipation gr2 SYSTEMATIC_ASSESSMENT Investigations None View
bilirubin gr4, ascites gr 3, hyponatremia gr 3, hyperk gr 3 SYSTEMATIC_ASSESSMENT Investigations None View
non-blistering rash gr 3 SYSTEMATIC_ASSESSMENT Investigations None View
increased confusion SYSTEMATIC_ASSESSMENT Investigations None View
muscle weakness gr3, myelosuppresion gr 3 SYSTEMATIC_ASSESSMENT Investigations None View
bilirubin gr 3, right upper quad pain gr 2 SYSTEMATIC_ASSESSMENT Investigations None View
n gr1, v gr1, d gr1, pain abd gr2, pain chest gr2, gastro viral gr2 SYSTEMATIC_ASSESSMENT Investigations None View
fracture gr 2 SYSTEMATIC_ASSESSMENT Investigations None View
syncope gr3 SYSTEMATIC_ASSESSMENT Investigations None View
syncope gr3, enceph gr 5, liver failure gr 5, GI bleed gr 3, death gr 5 SYSTEMATIC_ASSESSMENT Investigations None View
hepatic enceph gr 3, mood alteration gr 2, mental status change gr 3 SYSTEMATIC_ASSESSMENT Investigations None View
lower chest pressure SYSTEMATIC_ASSESSMENT Investigations None View
dizziness gr 3, dyspnea gr2, tumor pain gr 3, dehydration gr 3, confusion gr 1 SYSTEMATIC_ASSESSMENT Investigations None View
bronchitis, pleural effusion, dyspnea, lower extrem edema, rash SYSTEMATIC_ASSESSMENT Investigations None View
fever gr 2, chills gr 2, bilary obstruction gr2, sepsis gr 2 SYSTEMATIC_ASSESSMENT Investigations None View
expired secondary to disease SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
alk phos SYSTEMATIC_ASSESSMENT Investigations None View
alopecia SYSTEMATIC_ASSESSMENT Investigations None View
ALT /AST SYSTEMATIC_ASSESSMENT Investigations None View
ANC SYSTEMATIC_ASSESSMENT Investigations None View
anemia SYSTEMATIC_ASSESSMENT Investigations None View
anorexia SYSTEMATIC_ASSESSMENT Investigations None View
ascites SYSTEMATIC_ASSESSMENT Investigations None View
Ca SYSTEMATIC_ASSESSMENT Investigations None View
constipation SYSTEMATIC_ASSESSMENT Investigations None View
diarrhea SYSTEMATIC_ASSESSMENT Investigations None View
diverticulitis SYSTEMATIC_ASSESSMENT Investigations None View
dyspepsia SYSTEMATIC_ASSESSMENT Investigations None View
edema SYSTEMATIC_ASSESSMENT Investigations None View
esophageal stricture SYSTEMATIC_ASSESSMENT Investigations None View
fatigue SYSTEMATIC_ASSESSMENT Investigations None View
gastritis SYSTEMATIC_ASSESSMENT Investigations None View
hyperglycemia SYSTEMATIC_ASSESSMENT Investigations None View
HCT SYSTEMATIC_ASSESSMENT Investigations None View
hemorrhoids SYSTEMATIC_ASSESSMENT Investigations None View
Hyperbili SYSTEMATIC_ASSESSMENT Investigations None View
hyperalbumin SYSTEMATIC_ASSESSMENT Investigations None View
Hypoalbumin SYSTEMATIC_ASSESSMENT Investigations None View
Hypokalemia SYSTEMATIC_ASSESSMENT Investigations None View
Hypomagnesium SYSTEMATIC_ASSESSMENT Investigations None View
hyponatremia SYSTEMATIC_ASSESSMENT Investigations None View
infection-abdomen SYSTEMATIC_ASSESSMENT Investigations None View
lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
nausea SYSTEMATIC_ASSESSMENT Investigations None View
neuropathy SYSTEMATIC_ASSESSMENT Investigations None View
pain-abdomen SYSTEMATIC_ASSESSMENT Investigations None View
pain-extremeties SYSTEMATIC_ASSESSMENT Investigations None View
Pain-general/tumor SYSTEMATIC_ASSESSMENT Investigations None View
puritis SYSTEMATIC_ASSESSMENT Investigations None View
rash SYSTEMATIC_ASSESSMENT Investigations None View
thrmbocytopenia SYSTEMATIC_ASSESSMENT Investigations None View
URI SYSTEMATIC_ASSESSMENT Investigations None View
WBC SYSTEMATIC_ASSESSMENT Investigations None View