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: 2025-12-24 @ 12:34 PM
Ignite Modification Date: 2025-12-25 @ 12:11 PM
NCT ID: NCT00727961
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00727961
Study Brief: A Study to Evaluate Efficacy and Tolerance of Caelyx in Patients With Epithelial Ovarian Cancer. (Study P04072)(COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Caelyx Intravenous None None None 8 58 47 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
ALLERGIC TRANSFUSION REACTION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
BRONCHOSPASM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
VENOUS THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
STOMATITIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
BODY TEMPERATURE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
HYPOAESTHESIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
SKIN HYPERPIGMENTATION SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View