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 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT02384759
Description: None
Frequency Threshold: 5
Time Frame: Up to the end of treatment, on the average of 18 months. Death were monitored even the patient has stopped the study treatment (up to 3 years) whereas adverse events were monitored until the end of the study protocol (average of treatment=18 months)
Study: NCT02384759
Study Brief: Aflibercept +/- LV5FU2 in First Line of Non-resectalbe Metastatic Colorectal Cancers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LV5FU2 LV5FU2: LV5FU2 simplified every 2 weeks: folinic acid 400 mg/m2 IV over 90 min, then 5FU 400 mg/m2 IV bolus at D1, followed by continuous infusion of 5FU 2400 mg/m2 over 46 h. 36 None 13 56 56 56 View
Aflibercept + LV5FU2 LV5FU2: LV5FU2 simplified every 2 weeks: folinic acid 400 mg/m2 IV over 90 min, then 5FU 400 mg/m2 IV bolus at D1, followed by continuous infusion of 5FU 2400 mg/m2 over 46 h. Aflibercept : Preceded or not by an IV infusion of aflibercept 4 mg/kg over 1 hour 37 None 26 56 55 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thoracic Pain SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTC version 4.0 View
Auricular Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTC version 4.0 View
Cardiac insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders NCI-CTC version 4.0 View
AVC SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTC version 4.0 View
Cephalgia SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTC version 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTC version 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTC version 4.0 View
Mental confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders NCI-CTC version 4.0 View
Veinous thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTC version 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTC version 4.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTC version 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTC version 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders NCI-CTC version 4.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders NCI-CTC version 4.0 View
Burning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications NCI-CTC version 4.0 View
Dysphasia SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTC version 4.0 View
Cerebrovascular Ischemia SYSTEMATIC_ASSESSMENT Nervous system disorders NCI-CTC version 4.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTC version 4.0 View
Small bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI-CTC version 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders NCI-CTC version 4.0 View
Dorsalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders NCI-CTC version 4.0 View
Voice alteration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTC version 4.0 View
Epitaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders NCI-CTC version 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders NCI-CTC version 4.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders NCI-CTC version 4.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders NCI-CTC version 4.0 View