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 @ 1:05 AM
Ignite Modification Date: 2025-12-25 @ 11:18 PM
NCT ID: NCT00290693
Description: Adverse events reported for the 43 participants receiving at least one dose of protocol therapy.
Frequency Threshold: 2
Time Frame: None
Study: NCT00290693
Study Brief: Capecitabine and Docetaxel in Treating Patients With Recurrent or Progressive Metastatic Pancreatic 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
CapTere (Capecitabine + Docetaxel) Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle 42 None 25 43 20 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCAE (3.0) View
Hand and Foot Syndrome SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Pleural Effusions SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Mucositis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Hepatotoxicity SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Hand and foot syndrome SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View