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: NCT00345293
Description: Common toxicity criteria v4
Frequency Threshold: 0
Time Frame: None
Study: NCT00345293
Study Brief: Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DC/PC3 Vaccine 3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity None None 2 13 13 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
absolute lymphocyte, low SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
acid phosphatase, high SYSTEMATIC_ASSESSMENT General disorders None View
albumin, low SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
albumin, trace, urine SYSTEMATIC_ASSESSMENT General disorders None View
alkaline phosphatase, high SYSTEMATIC_ASSESSMENT General disorders None View
ALT, high SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ANA, high SYSTEMATIC_ASSESSMENT General disorders None View
ANC, low SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
AST, high SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
bacteria, urine, few SYSTEMATIC_ASSESSMENT General disorders None View
basophil, high SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
bilirubin, urine, small SYSTEMATIC_ASSESSMENT General disorders None View
blood, urine, trace SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
BUN, high SYSTEMATIC_ASSESSMENT General disorders None View
calcium, ionized, low SYSTEMATIC_ASSESSMENT General disorders None View
chloride, high SYSTEMATIC_ASSESSMENT General disorders None View
CO2, high SYSTEMATIC_ASSESSMENT General disorders None View
cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
creatinine, high SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
crystals, urine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
glucose, high SYSTEMATIC_ASSESSMENT General disorders None View
glucose, low SYSTEMATIC_ASSESSMENT General disorders None View
headache SYSTEMATIC_ASSESSMENT General disorders None View
heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hematocrit, low SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
hematoma SYSTEMATIC_ASSESSMENT General disorders None View
hemoglobin, low SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
hemorrhage, GU, bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
epistaxis SYSTEMATIC_ASSESSMENT General disorders None View
injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
INR, low SYSTEMATIC_ASSESSMENT General disorders None View
ketones, urine, high SYSTEMATIC_ASSESSMENT General disorders None View
leuko est, urine, high SYSTEMATIC_ASSESSMENT General disorders None View
lightheadedness SYSTEMATIC_ASSESSMENT General disorders None View
low back pain SYSTEMATIC_ASSESSMENT General disorders None View
LUC, high SYSTEMATIC_ASSESSMENT General disorders None View
lymphocytes, %, low SYSTEMATIC_ASSESSMENT General disorders None View
MCHC, high SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
monocytes, %, high SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
neutrophils, %, high SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
neutrophils, %, low SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
numbness/tingling SYSTEMATIC_ASSESSMENT General disorders None View
chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
pain SYSTEMATIC_ASSESSMENT General disorders None View
pH, urine, high SYSTEMATIC_ASSESSMENT General disorders None View
platelet, high SYSTEMATIC_ASSESSMENT General disorders None View
platelets, low SYSTEMATIC_ASSESSMENT General disorders None View
potassium, high SYSTEMATIC_ASSESSMENT General disorders None View
presyncope SYSTEMATIC_ASSESSMENT General disorders None View
Prolonged QTc interval SYSTEMATIC_ASSESSMENT Cardiac disorders None View
pulmonary nodules SYSTEMATIC_ASSESSMENT General disorders None View
rash SYSTEMATIC_ASSESSMENT General disorders None View
RBC, low SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
RBC, urine, high SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RDW, high SYSTEMATIC_ASSESSMENT General disorders None View
rheumatoid factor, positive SYSTEMATIC_ASSESSMENT General disorders None View
rosecea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
seasonal allergies SYSTEMATIC_ASSESSMENT Immune system disorders None View
specific gravity, urine, high SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
specific gravity, urine, low SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
swollen glands SYSTEMATIC_ASSESSMENT General disorders None View
thyroid nodules SYSTEMATIC_ASSESSMENT General disorders None View
total bilirubin, high SYSTEMATIC_ASSESSMENT General disorders None View
total protein, low SYSTEMATIC_ASSESSMENT General disorders None View
URI SYSTEMATIC_ASSESSMENT General disorders None View
vasovagal episode SYSTEMATIC_ASSESSMENT General disorders None View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
WBC, low SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View