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: 2025-12-26 @ 1:16 PM
Ignite Modification Date: 2025-12-26 @ 1:16 PM
NCT ID: NCT01129206
Description: Toxicities were defined by the National Cancer Institutes CTCAE version 3.0
Frequency Threshold: 5
Time Frame: None
Study: NCT01129206
Study Brief: Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm I Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2. docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days. fludeoxyglucose F 18: Correlative studies positron emission tomography: Correlative studies None None 0 6 6 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE version 3.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE version 3.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Investigations CTCAE version 3.0 View
Mucocitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE version 3.0 View