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 @ 11:25 PM
Ignite Modification Date: 2025-12-25 @ 9:11 PM
NCT ID: NCT02181556
Description: Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Frequency Threshold: 5
Time Frame: Up to the end of treatment, on average of 8 months
Study: NCT02181556
Study Brief: Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With 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
FOLFIRI and Aflibercept FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease FOLFIRI + Aflibercept: injection of FOLFIRI and Aflibercept every 14 days until progression of disease 25 None 13 40 36 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Large intestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Large intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Small intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Colonic perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders NCI CTC version 4.0 View
Venous TE disorders SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTC version 4.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders NCI CTC version 4.0 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders NCI CTC version 4.0 View
Anemia SYSTEMATIC_ASSESSMENT Investigations NCI CTC version 4.0 View
Leucopenia SYSTEMATIC_ASSESSMENT Investigations NCI CTC version 4.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Investigations NCI CTC version 4.0 View