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 @ 7:57 PM
Ignite Modification Date: 2025-12-25 @ 5:31 PM
NCT ID: NCT00881504
Description: None
Frequency Threshold: 0
Time Frame: 8 weeks
Study: NCT00881504
Study Brief: A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FOLFOX6 and Bevacizumab Treatment with modified FOLFOX6 and Bevacizumab Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay \> 4 weeks None None 1 8 8 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Perforation of colon SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
low platelet count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
anorexia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
hypoalbuminemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
hypocalcemia SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders CTCAE (3.0) View
mucositis/stomitis SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
hyponatremia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View