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 @ 10:01 PM
Ignite Modification Date: 2025-12-25 @ 7:38 PM
NCT ID: NCT00454532
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00454532
Study Brief: A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast 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
Level 1 10g/day None None 5 11 11 11 View
Level 2 20g/day None None 0 6 6 6 View
Level 3 30g/day None None 1 3 3 3 View
Level 4 40g/day None None 4 7 7 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pain-liver SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Thrombosis left iliac vein SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Obstruction-gu ureter SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE 3.0 View
Hemorrhage gu-bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (3.0) View
Hemorrhage, GI-abdomen NOS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pain-breast SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (3.0) View
Hemoglobin SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Pain-rib cage due to vomiting SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (3.0) View
Infection-ulcer SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Pain-headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
Distension/bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pain-abdomen NOS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (3.0) View
ALT elevation SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
AST elevation SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View
Decreased hemoglobin SYSTEMATIC_ASSESSMENT Investigations CTCAE (3.0) View