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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:53 PM
NCT ID: NCT01148056
Description: Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
Frequency Threshold: 0
Time Frame: 30 Days
Study: NCT01148056
Study Brief: Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal 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
Short Course IMRT Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days None None 0 2 2 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
confusion SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
elevated bilirubin SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
low phosphorus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
edema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
pilonidal abscess SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View