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 @ 9:10 PM
Ignite Modification Date: 2025-12-25 @ 7:00 PM
NCT ID: NCT02319304
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected while participants were completing active treatment (approximately 6 weeks) and post-treatment (up to 13 additional weeks).
Study: NCT02319304
Study Brief: Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX for Patients With Newly Diagnosed Rectal Adenocarcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX Part I: FOLFOX: combination of drugs administered in a specific sequence as prescribed below. * Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours * Leucovorin: 200 mg/m2 IV bolus over 2 hours * 5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours Part II: Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}: see arm description Low dose fractionated radiation therapy (LDFRT): see arm description 0 None 1 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutrophil Count Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
White Blood Cell Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Platelet count Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
White Blood Cell Decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (4.0) View
Fever SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View