Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-25 @ 2:38 AM
Ignite Modification Date: 2025-12-26 @ 1:16 AM
NCT ID: NCT00541034
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00541034
Study Brief: Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Patients All patients who received cyclophosphamide, pentostatin and rituximab None None 18 49 49 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Dyspnea SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Facial pain SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTC-3.0 View
Immune system disorder SYSTEMATIC_ASSESSMENT Immune system disorders CTC-3.0 View
Joint pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC-3.0 View
Localized edema SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Muscle weakness lower limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC-3.0 View
Muscle weakness upper limb SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTC-3.0 View
Pharyngeal mucositis SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Pneumonia SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Rash desquamating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTC-3.0 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations CTC-3.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ALT, SGPT SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
AST, SGOT SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Albumin, low (hypoalbuminemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-3.0 View
Bilirubin (hyperbilirubinemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-3.0 View
Creatinine SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-3.0 View
Distension/bloating, abdominal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-3.0 View
Fatigue (asthenia, lethargy, malaise) SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Glucose, high (hyperglycemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-3.0 View
Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Leukocytes (total WBC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTC-3.0 View
Neutrophils/granulocytes (ANC/AGC) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View
Phosphate, low (hypophosphatemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-3.0 View
Platelets SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTC-3.0 View
Potassium, high (hyperkalemia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-3.0 View
Sodium, low (hyponatremia) SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTC-3.0 View
Tumor lysis syndrome SYSTEMATIC_ASSESSMENT General disorders CTC-3.0 View