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 @ 4:07 AM
Ignite Modification Date: 2025-12-26 @ 3:04 AM
NCT ID: NCT01669720
Description: None
Frequency Threshold: 0
Time Frame: Every 2 weeks until 30 days post last dose of drug
Study: NCT01669720
Study Brief: Adjuvant Aflibercept for Metastatic Colorectal 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
Aflibercept Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years None None 0 7 6 7 View
Observation Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention. None None 0 3 2 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
HTN SYSTEMATIC_ASSESSMENT Investigations None View
Bronchial infection SYSTEMATIC_ASSESSMENT Investigations None View
UTI SYSTEMATIC_ASSESSMENT Investigations None View
ALK SYSTEMATIC_ASSESSMENT Investigations None View
Glu SYSTEMATIC_ASSESSMENT Investigations None View
proteinuria SYSTEMATIC_ASSESSMENT Investigations None View
PLT SYSTEMATIC_ASSESSMENT Investigations None View
AST SYSTEMATIC_ASSESSMENT Investigations None View
ALT SYSTEMATIC_ASSESSMENT Investigations None View
bruising SYSTEMATIC_ASSESSMENT Investigations None View
Hoarseness SYSTEMATIC_ASSESSMENT Investigations None View
akathisia/restlessness SYSTEMATIC_ASSESSMENT Investigations None View
cough SYSTEMATIC_ASSESSMENT Investigations None View
fever SYSTEMATIC_ASSESSMENT Investigations None View
rash SYSTEMATIC_ASSESSMENT Investigations None View
Anemia SYSTEMATIC_ASSESSMENT Investigations None View
fatigue SYSTEMATIC_ASSESSMENT Investigations None View
lymph SYSTEMATIC_ASSESSMENT Investigations None View
Sodium SYSTEMATIC_ASSESSMENT Investigations None View
Edema- localized SYSTEMATIC_ASSESSMENT Investigations None View
pain-hip/leg, mouth, abd SYSTEMATIC_ASSESSMENT Investigations None View
headache SYSTEMATIC_ASSESSMENT Investigations None View
mucositis SYSTEMATIC_ASSESSMENT Investigations None View
creatinine SYSTEMATIC_ASSESSMENT Investigations None View
WBC SYSTEMATIC_ASSESSMENT Investigations None View
dizziness SYSTEMATIC_ASSESSMENT Investigations None View
neuropathy SYSTEMATIC_ASSESSMENT Investigations None View
arthralgia SYSTEMATIC_ASSESSMENT Investigations None View
weight gain SYSTEMATIC_ASSESSMENT Investigations None View
constipation SYSTEMATIC_ASSESSMENT Investigations None View
vision-blurry SYSTEMATIC_ASSESSMENT Investigations None View
increased hemoglobin SYSTEMATIC_ASSESSMENT Investigations None View
insomnia SYSTEMATIC_ASSESSMENT Investigations None View
anorexia SYSTEMATIC_ASSESSMENT Investigations None View
Anxiety SYSTEMATIC_ASSESSMENT Investigations None View
Hypokalemia SYSTEMATIC_ASSESSMENT Investigations None View